5900 Optical Court

San Jose, CA 95138

stryker
t: 408 754 2000 f: 408 754 2505 Endoscopy
www.stryker.com

DECLARATION OF CONFORMITY
European Medical Device Directive 93/42/EEC

DoC Number: DECL10009, Rev. G

Manufacturer: EC Authorized Representative Registration Number and Report Number

STRYKER ENDOSCOPY ECIREPI Registration Number: SX 60104850
5900 Optical Court Stryker European Operations B.V. 0001
San Jose, CA 95138, Tlerikerbergweg 110
Arnaterd wn
USA 1101 CM Report Number: 31492313 001
Tel: (408 754 2000 Netherlands
Fax: (408) 754 2505

Product Family Name: (See Annex: Product List)

Product Class and Rule: (See Annex: Product List)

(1) According to Annex VII of the Council Directive 93/42/EEC concerning Medical Devices, we declare under our
sole responsibility that the distributed CE marked products specified in the annexed product list, meet the
provisions of the Council Directive 93/42/EEC concerning medical devices, which apply to them.

Conformity assessment was performed according to Annex VII.

This declaration is supported by Quality System Certificate for the products concerned. The conformity to quality
assurance set out in the said EN lSO13485:2012/AC:2012 Conformity Certificate number (SX 60104850 0001),
issued and delivered by TUV Rheinland, LGA Products GmbH, TiIIystrae 2, 90431 Nuremberg, Germany.

(2) We declare, under our sole responsibility, that the products specified in the annexed product list conform to
the harmonized standard EN 50581, and thereby comply with the R0HS2 Directive, 2011/65/EU. It should be noted
that this statement is applicable to only those part numbers in the annexed product list for which the R0HS2
Directive, 2011/65/EU, is applicable.

Issue date: 20-Jul-2016

(Validity date)

Signed for and behalf of Stryker Endoscopy by:

5:)

Date: 30-Aug-2016 Kimberly Lynch

Regulatory Compliance Manager

This declaration is valid until: 01-Oct-2018

DWI1017.01, Rev. C
5900 Optical Court stryker
San Jose, CA 95138
t: 408 754 2000 f: 408 754 2505 Endoscopy
www.stryker.com

Annex - Product List

This product list belongs to the Declaration of Conformity identified by Stryker Endoscopy and specifies
the CE marked products concerned that Stryker Endoscopy intends to distribute in conformity with the
provisions of Council Directive 93/42/EEC concerning medical devices and Council Directive 2011/65/Eu
concerning electrical and electronic equipment.

The following list identifies the products by Catalogue number and type.

Product Family Name: L9000 LED Light Source

Catalogue Number Product Name Product Class and Rule

0220210000 L4000 LFP LightSource L , Liile i

DWI1017.01, Rev. C
 5900 Optical Court
stryker
San Jose, CA 95138
t: 408 754 2000 f: 408 754 2505 Endoscopy
www.stryker.com

DECLARATION OF CONFORMITY
European Medical Device Directive 93/42/EEC

DoC Number: DECL10021, Rev. F

Manufacturer: EC Authorized Representative Registration Number and Report
Number
STRYKER ENDOSCOPY Strker European Representative Registration Number: SX60104850
Regulatory Manager, Stryker
5900 Optical Court France 0001
San Jose, CA 95138, ZAC Salolas Green Pusignan
Av. dc Satolas Gicen
USA 69881 France Report Number: 31492313 001
Tel: (408) 754 2000
Fax: (408) 754 2505

Product Family Name: (See Annex: Product List)

Product Class and Rule: (See Annex: Product List)

(1) According to Annex VII of the Council Directive 93/42/EEC concerning Medical Devices, we declare under
our sole responsibility that the distributed CE marked products specified in the annexed product list, meet
the provisions of the Council Directive 93/42/EEC concerning medical devices, which apply to them.

Conformity assessment was performed according to Annex VII.

This declaration is supported by Quality System Certificate for the products concerned. The conformity to
quality assurance set out in the said EN ISO 13485:2012/AC:2012 Conformity Certificate number SX 60104850
0001, issued and delivered by TUV Rheinland, LGA Products GmbH, Tillystrae 2, 90431 Nuremberg,
Germany.

(2) We declare, under our sole responsibility, that the products specified in the annexed product list conform
to the harmonized standard EN 50581, and thereby comply with the RoHS2 Directive, 2011/65/Eu. It should
be noted that this statement is applicable to only those part numbers in the annexed product list for which
the RoHS2 Directive, 2011/65/Eu, is applicable.

Issue date: 8-Aug-2016

Signed for and behalf of Stryker Endoscopy by:

_J~~
Date:
q~_~
Kimberly Lynch
Avv4 )- 01 to Regulatory Compliance Manager

This declaration is valid until: 24-Sep-2016

DWI1017.01 Rev C
5900 Optical Court
stryker®
San Jose, CA 95138
t: 408 754 2000 f:408 7542505 Endoscopy
www.stiyker.com

Annex - Product Li

This product list belongs to the Declaration of Conformity identified by Stryker Endoscopy and
specifies the CE marked products concerned that Stryker Endoscopy intends to distribute in
conformity with the provisions of Council Directive 93/42/EEC concerning medical devices and
Council Directive 2011/65/Eu concerning electrical and electronic equipment.

The following list identifies the products by Catalogue number and type.

Product Family Name: 26" Vision Elect HDTV Surgical Viewing MonitorTM

Catalogue Product Name Product Class and

Number Rule
0240030930 Vision Elect® 21" Flat Display Class I, Rule 12
0240030951 DC Extension Cable for Vision Elect HDTV (5-Pin), 15 ft Class I, Rule 12
0240-030-952 DC Extension Cable for Vision Elect HDTV (5 pin), 75 ft. Class I, Rule 12
0240-031-004 Medical Power Supply for 26" Display Class I, Rule 12

DW11017.01 Rev C
 5900 Optical Court
stryker®
San Jose, CA 95138
t: 408 754 2000 f: 408 754 2505 Endoscopy
www.stryker.com

DECLARATION OF CONFORMITY
European Medical Device Directive 93/42/EEC

DoC Number: DECL10021, Rev. F

Manufacturer: EC Authorized Representative Registration Number and Report
Number
STRYKER ENDOSCOPY European Operations B.V. Registration Number: SX
EC REP Herikerbergweg 110
5900 Optical Court Amsterdam 60104850 0001
San Jose, CA 95138, 1101CM
Netherlands
USA Report Number: 31492313 001
Tel: (408) 754 2000
Fax: (408) 754 2505

Product Family Name: (See Annex: Product List)

Product Class and Rule: (See Annex: Product List)

(1) According to Annex VII of the Council Directive 93/42/EEC concerning Medical Devices, we declare under
our sole responsibility that the distributed CE marked products specified in the annexed product list, meet
the provisions of the Council Directive 93/42/EEC concerning medical devices, which apply to them.

Conformity assessment was performed according to Annex VII.

This declaration is supported by Quality System Certificate for the products concerned. The conformity to
quality assurance set out in the said EN ISO 13485:2012/AC:2012 Conformity Certificate number SX 60104850
0001, issued and delivered by TUV Rheinland, LGA Products GmbH, TilIystrae 2, 90431 Nuremberg,
Germany.

(2) We declare, under our sole responsibility, that the products specified in the annexed product list conform
to the harmonized standard EN 50581, and thereby comply with the RoHS2 Directive, 2011/65/EU. It should
be noted that this statement is applicable to only those part numbers in the annexed product list for which
the RoHS2 Directive, 2011/65/EU, is applicable.

Issue date: 8-Aug-2016

Signed for and behalf of Stryker Endoscopy by:

Date: Kimberly Lynch

AV441 oI Regulatory Compliance Manager

This declaration is valid until: 01-Oct-2018

DWI1017.01 Rev C
5900 Optical Court
stryker®
San Jose, CA 95138
t: 408 754 2000 f: 408 754 2505 Endoscopy
www.stryker.com

Annex - Product List

This product list belongs to the Declaration of Conformity identified by Stryker Endoscopy and
specifies the CE marked products concerned that Stryker Endoscopy intends to distribute in
conformity with the provisions of Council Directive 93/42/EEC concerning medical devices and
Council Directive 2011/65/EU concerning electrical and electronic equipment.

The following list identifies the products by Catalogue number and type.

Product Family Name: 26" Vision Elect HDTV Surgical Viewing MonitorTM

Catalogue Product Name Product Class and

Number Rule
0240-030-930
0240-030-951
0240-030-952
Vision ElectO 21" Flat Display
DC Extension Cable for Vision Elect HDTV
DC Extension Cable for Vision Elect HDTV (5
Cl a
Class

jni1 IiI
Class
ss
[Iø$ItT Medical Power Supply for 26"' Display Class 1, Rule 12

DWI1017.01 Rev C
 5900 Optical Court stryker®
San Jose, CA 95138
t: 408 754 2000 f: 408 754 2505

www.stryker.com

DECLARATION OF CONFORMITY
European Medical Device Directive 93/42/EEC

DoC Number: DECL10030, Rev. E

Manufacturer: EC Authorized Representative Registration Number and Report Number

STRYKER ENDOSCOPY Registration Number: SX 60104850 0001
5900 Optical Court ECREP
San Jose, CA 95138, Stryker European Representative Report Number: 31492313 001
USA Regulatory Manager, Stryker France
Tel: (408) 754 2000 ZAC Satolas Green Pusignan
Fax: (408) 754 2505 Av. de Satolas Green
69881 MEYZIEU Cedex, France

Product Family Name: (See Annex: Product List)

Product Class and Rule: (See Annex: Product List)

(1) According to Annex VII of the Council Directive 93/42/EEC concerning Medical Devices, we declare under our sole
responsibility that the distributed CE marked products specified in the annexed product list, meet the provisions of
the Council Directive 93/42/EEC concerning medical devices, which apply to them.

Conformity assessment was performed according to Annex VII.

This declaration is supported by Quality System Certificate for the products concerned. The conformity to quality
assurance set out in the said EN ISO 13485:2012/AC:2012 Conformity Certificate number (SX 601048500001), issued
and delivered byTUV Rheinland, LGA Products GmbH, Tillystrae 2, 90431 Nuremberg, Germany.

(2) We declare, under our sole responsibility, that the products specified in the annexed product list conform to the
harmonized standard EN 50581, and thereby comply with the RoHS2 Directive, 2011/65/EU. It should be noted that
this statement is applicable to only those part numbers in the annexed product list for which the RoHS2 Directive,
2011/65/EU, is applicable.

Issue date: I b i,L(

Signed for and behalf of Stryker Endoscopy by:

Date h IC t)t' Kimberly Lynch

Regulatory Compliance Manager
This declaration is valid until: 01-OCT-2018

DWI1017.01, Rev. C
5900 Optical Court
stryker
San Jose, CA 95138
t: 408 754 2000 f: 408 754 2505

www.stryker.com

Annex - Product List

This product list belongs to the Declaration of Conformity identified by Stryker Endoscopy and specifies
the CE marked products concerned that Stryker Endoscopy intends to distribute in conformity with the
provisions of Council Directive 93/42/EEC concerning medical devices and Council Directive 2011/65/EU
concerning electrical and electronic equipment.

The following list identifies the products by Catalogue number and type.

Product Family Name: Operating room device management system- Digital Color Printer SDP1000

Catalogue Product Name Product Class

Number and Rule
Stt yKe riniei (SDP1000) , L k

240-080-231 Letter Size Media (SEPC-110)- includes 2 rolls of paper w/ 50 Class I, Rule 1
sheets each and 2 ribbons w/ capacity for 50 prints each
P4 Size Meda (SEPC-J00)-- includes 2 rolls of paper w/ 50 C0ss 2Lz
sheets each and .21 Obbons w/ capacity fo 50 prints each
' 4, 0-080-234
,L Pack of 20 C l eaning, Sheets for SDP1000 Printer Class h uk i
2e08tS2 Pkg. Pack of tO Cleaning Sheets Cssz i, Sule

DWI 1O17.01, Rev. C

 5900 Optical Court
stryker
San Jose, CA 95138
t: 408 754 2000 f:408 7542505
www.stryker.com

DECLARATION OF CONFORMITY
European Medical Device Directive 93/42/EEC

DoC Number: DECL10032, Rev. H

Manufacturer: EC Authorized Representative Registration Number and Report Number

STRYKER ENDOSCOPY
EC I REP Registration Number: SX 60104850
5900 Optical Court Stryker European Operations B.V. 0001
San Jose, CA 95138, Herikerbergweg 110
USA Am sterd a ni Report Number: 31492313 001
Tel: (408) 754 2000 1101 CM
Fax: (408) 754 2505 Netherlands

Product Family Name: (See Annex: Product List)

Product Class and Rule: (See Annex: Product List)

(1) According to Annex VII of the Council Directive 93/42/EEC concerning Medical Devices, we declare under our
sole responsibility that the distributed CE marked products specified in the annexed product list, meet the
provisions of the Council Directive 93/42/EEC concerning medical devices, which apply to them.

Conformity assessment was performed according to Annex VII.

This declaration is supported by Quality System Certificate for the products concerned. The conformity to quality
assurance set out in the said EN ISO 13485:2012/AC:2012 Conformity Certificate number (SX 60104850 0001),
issued and delivered by TUV Rheinland, LGA Products GmbH, TiIIystra1e 2, 90431 Nuremberg, Germany.

(2) We declare, under our sole responsibility, that the products specified in the annexed product list conform to
the harmonized standard EN 50581, and thereby comply with the R0HS2 Directive, 2011/65/EU. It should be noted
that this statement is applicable to only those part numbers in the annexed product list for which the RoHS2
Directive, 2011/65/EU, is applicable.

Issue date: 26-AUG-2016

(Validity date)

Signed for and behalf of Stryker Endoscopyby: (1)

Date: A Kimberly Lynch

Regulatory Compliance Manager

This declaration is valid until: 01-OCT-2018

DWII017.01. Rev. C
5900 Optical Court stryker®
San Jose, CA 95138
t: 408 754 2000 f: 408 754 2505
www.stryker.com

Annex - Product List

This product list belongs to the Declaration of Conformity identified by Stryker Endoscopy and specifies
the CE marked products concerned that Stryker Endoscopy intends to distribute in conformity with the
provisions of Council Directive 93/42/EEC concerning medical devices and Council Directive 2011/65/Eu
concerning electrical and electronic equipment.

The following list identifies the products by Catalogue number and type.

Product Family Name: Medical Video Systems, 1488 HD Camera and Coupler

Catalogue Product Name Product Class

Number and Rule
1488010000 1488 HD 3 Chip Camera Control Unit Class I, kuic 1
1488010001 1488 HD 3 Chip Camera Control Unit with DVI Fiber Output Class I, We 12
1488710105 1488 HD 3-Chip Camera Head, C-Mount Class I, Niule 12
1488710105 1488 HD 3-Chip Inline Camera Head, C-Mount, 0 Class I, Rule 12
14C-0z0.122 1488 HD Coupler, C-mount, 18 mm Class i, LwIe 12
1488-020-125 Ideal Eyes® Zoom Coupler, C-Mount Class I, Rule 12
1488610122 1488 HD 3-Chip Camera Head with Integrated Coupler Class I, Rule 12
1488310130 1488 HD 3-Chip Pendulum Camera Head with Integrated Class I, Rule 12
Couoler

DWI1017.01, Rev. C
5900 Optical Court
San Jose, CA 95138
.stryker
t: 408 754 2000 f: 408 754 2505 Endoscopy
svwwstrykercom

DECLARATION OF CONFORMITY

European Medical Device Directive 93/42/EEC

DoC Number: DECL10106, Rev. D

Manufacturer: EC Authorized Representative Registration Number and Report Number
-

STRYKER ENDOSCOPY J ECJREP Registration Number: \ 60 1048 5 0

5900 Optical Court S tryker EUIOIKIn operations B V 0001
San Jose, CA 95138, 11e6kerhergwe Ito
Anuterdam
USA 1101 CM Report Number. 31492313 001
Tel: (408) 754 2000 Netherlands
Fax: (408) 754 2505

Product Family Name: (See Annex: Product List)

Product Class and Rule: (See Annex: Product List)

(1) According to Annex VII of the Council Directive 93/42/EEC concerning Medical Devices, we
declare under our sole responsibility that the distributed CE marked products specified in the
annexed product list, meet the provisions of the Council Directive 93/42/EEC concerning medical
devices, which apply to them.

Conformity assessment was performed according to Annex VII.

This declaration is supported by Quality System Certificate for the products concerned. The
conformity to quality assurance set out in the said EN ISO 13485:2012/AC:2012 Conformity
Certificate number SX 60104850 0001, issued and delivered by TUV Rheinland, LGA Products
GmbH, Tillystrae 2, 90431 Nuremberg, Germany.

(2) We declare, under our sole responsibility, that the products specified in the annexed product
list conform to the harmonized standard EN 50581, and thereby comply with the RoHS2 Directive,
2011/65/EU. It should be noted that this statement is applicable to only those part numbers in
the annexed product list for which the RoHS2 Directive, 2011/65/EU, is applicable.

Issue date: 04-Nov-2016

(Validity date)

Signed for and behalf of Stryker Endoscopy by:

Date: Kimberly Lynch

Regulatory Compliance Manager

This declaration is valid until: 01-Oct-2018

DWI IO17.01,Rev. C
5900 Optical Court
San Jose, CA 95138
stryker
t: 408 754 2000 f: 408 754 2505 Endoscopy
www.stryker.com

Annex - Product List

This product list belongs to the Declaration of Conformity identified by Stryker Endoscopy and
specifies the CE marked products concerned that Stryker Endoscopy intends to distribute in
conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices.

The following list identifies the products by Catalogue number and type.

Product Family Name: Safelight Cable and Adapters

Catalogue Number Product Name Product Class and

Rule
..hLV, ..
Ruic
(.)•'mpsC Ru
1 Ku

02300192 sal-ehaht"il Ut curt Scope AMp1er Class I Rule I

DWII0I7.01, Rev. C
 5900 Optical Court stryker®
San Jose, CA 95138
t: 408 754 2000 f:408 7542505
www.stryker.com

DECLARATION OF CONFORMITY
European Medical Device Directive 93/42/EEC

DoC Number: DECL10108, Rev. _G

Manufacturer: EC Authorized Representative Registration Number and Report
Number
STRYKER ENDOSCOPY European Operations B.%'. Registration Number: SX 60104850
ECIREP Herikerherawe 100
5900 Optical Court Amsterdam 0001
San Jose, CA 95138, 1101 CM
Netherlands
USA Report Number: 3 14923 13 001
Tel: (408) 754 2000
Fax: (408) 754 2505

Product Family Name: (See Annex: Product List)

Product Class and Rule: (See Annex: Product List)

(1) According to Annex VII of the Council Directive 93/42/EEC concerning Medical Devices, we declare under our
sole responsibility that the distributed CE marked products specified in the annexed product list, meet the
provisions of the Council Directive 93/42/EEC concerning medical devices, which apply to them.

Conformity assessment was performed according to Annex VII.

This declaration is supported by Quality System Certificate for the products concerned. The conformity to quality
assurance set out in the said EN 15013485:2012/AC:2012 Conformity Certificate number SX 60104850 0001, issued
and delivered by TUV Rheinland, LGA Products GmbH, TillystraRe 2, 90431 Nuremberg, Germany.

(2) We declare, under our sole responsibility, that the products specified in the annexed product list conform to
the harmonized standard EN 50581, and thereby comply with the R0HS2 Directive, 2011/65/EU. It should be noted
that this statement is applicable to only those part numbers in the annexed product list for which the RoHS2
Directive, 2011/65/EU, is applicable.

Issue date: 26-Aug-2016

(Validity date)

Signed for and behalf of Stryker Endoscopy by

Date: L Kimberly Lynch

2 2c 1 i Regulatory Compliance Manager

This declaration is valid until: 01-OCT-2018

DWI1017.01, Rev. C
5900 Optical Court
San Jose, CA 95138
stryker®
t: 408 754 2000 f: 408 754 2505
www.stryker.com

Annex - Product List

This product list belongs to the Declaration of Conformity identified by Stryker Endoscopy and specifies
the CE marked products concerned that Stryker Endoscopy intends to distribute in conformity with the
provisions of Council Directive 93/42/EEC concerning medical devices and Council Directive 2011/65/EU
concerning electrical and electronic equipment.

The following list identifies the products by Catalogue number and type.

Product Family Name: Endoscopic Hardware

Catalogue Product Class and

Product Name
Number Rule
0233032104 Sterilization Tray for Autoclavable Arthroscopes Class I, Rule 1
0233032105 Sterilization Tray for Arthroscope and Camera Class I, Rule 1
0233032107 Sterilization Tray for Endoscopic Scope and Camera Class I, Rule 1
0233032108 Sterilization Tray for Laparoscopes Class 1, Rule 1
0233032111 Sterilization Tray for Bariatric Laparoscopes Class I, Rule 1
0233032116 Sterilization Tray Arthroscope & Hardware Set Tray Class I, Rule 1
0233032800 Sterilization Tray for Flexible Urology Instruments Class I Rule 1
0233032880 Sterilization Tray for Urology/Gynecology Accessories, Single Tier Class I, Rule 1
Sterilization Tray for Urology/Gynecology Instruments, Two
0233032881 Class I, Rule 1
Tier
0233410000 Sterilization Tray for Autoclavable Camera Class I, Rule 1
0250-080-154 Trocar, Pyramidal Tip, 5.5 mm Class I, Rule 6
0250-080-156 Trocar, Pyramidal Tip, 11.0 mm Class I, Rule 6
0250-080-157 Obturator for Hasson Cannula, 5.5 mm Class I, Rule 6
0250-080-158 Obturator for Hasson Cannula, 11.0 mm Class I, Rule 6
0250-080-422 Trocar Pyramidal Tip, 12.5 mm Class I, Rule 6
Replacement Sealing Caps for 11.0 mm Cann ulas/Reducers
0250080623 Class I, Rule IL
(5/kit)
0377-030-300 Cannulated Trocar for Hip Scope Class I, Rule 6
0377-030-400 Cannulated Obturator for Hip Scope Class I, Rule 6
0502577015 Cannulated Pencil-Tip Obturator for Long 5.8 mm Cannula Class I, Rule 6

DWII017.01, Rev. C
 0

5900 Optical Court

SIM
San Jose, CA 95138
d408 754 2000 f: 408 754 2505

www.stryker.com

DECLARATION OF CONFORMITY
European Medical Device Directive 93/42/EEC

DoC Number: DECL10120, Rev. C

Manufacturer: EC Authorized Representative Registration Number and Report Number

STRYKER ENDOSCOPY I Registration Nuber:
m 51(60104850 0001
5900 Optical Court ECREPI
San Jose, CA 95138, Stryker European Representative Report Number: 31492313 001
USA Regulatory Manager, Stryker France
Tel: (408) 754 2000 ZAc Satolas Green Pusignan
Fax: (408) 754 2505 Av. do Satolas Green
69881 MEYZIEU Cedex, France

Product Family Name: (See Annex: Product List)

Product Class and Rule: (See Annex: Product List)

(1) According to Annex VII of the Council Directive 93/42/EEC concerning Medical Devices, we declare under our sole
responsibility that the distributed CE marked products specified in the annexed product list, meet the provisions of
the Council Directive 93/42/EEC concerning medical devices, which apply to them.

Conformity assessment was performed according to Annex VII.

This declaration is supported by Quality System Certificate for the products concerned. The conformity to quality
assurance set out in the said EN ISO 13485:2012/AC:2012 Conformity Certificate number (SX 60104850 0001), issued
and delivered by TUV Rheinland, LGA Products GmbH, Tillystrae 2, 90431 Nuremberg, Germany.

(2) We declare, under our sole responsibility, that the products specified in the annexed product list conform to the
harmonized standard EN 50581, and thereby comply with the RoHS2 Directive, 2011/65/EU. It should be noted that
this statement is applicable to only those part numbers in the annexed product list for which the RoHS2 Directive,
2011/65/EU, is applicable.

Issue date: 26-Jan-2016

Signed for and behalf of Stryker Endoscopy by:

j c"—
Date Kimberly Ly Uh
Regulatory Compliance Manager

This declaration is valid until: 01-OCT-2018

DWI1017.01, Rev. B
5900 Optical Court
P771gg
San Jose, CA 95138
t: 408 754 2000 f: 408 754 2505

www.stryker.com

Annex - Product List

This product list belongs to the Declaration of Conformity identified by Stryker Endoscopy and specifies
the CE marked products concerned that Stryker Endoscopy intends to distribute in conformity with the
provisions of Council Directive 93/42/EEC concerning medical devices and Council Directive 2011/65/EU
concerning electrical and electronic equipment.

The following list identifies the products by Catalogue number and type.

Product Family Name: Carts and Stands

Catalogue Number Product Name Product Class and Rule
240-030-922 SV-2 Desktop Stand Class I, Rule 1
351-600-000 Micro Cart Class I, Rule 1
240-099-110 Flat Panel Roll Stand Class I, Rule 1
240-099-109 Pkg, Roll Stand Base Class I, Rule 1

DWI10I7.01, Rev. B
 5900 Optical Court stryker®
San Jose, CA 95138
t: 408 754 2000 f: 408 754 2505
www.stryker.com

DECLARATION OF CONFORMITY
European Medical Device Directive 93/42/EEC

DoC Number: DECL10211, Rev. A

Manufacturer: EC Authorized Representative Registration Number and Report Number

STRYKER ENDOSCOPY Registration Number: SX 60104850 0001
5900 Optical Court llNFl
San Jose, CA 95138, Stryker European Representative
Report Number: 31492313 001
Regulatory Manager, Stryker France
USA
ZAC Satolas Green Pusignan
Tel: (408) 754 2000
Av. de Satolas Green
Fax: (408) 754 2505 69881 MEYZIEU Cedex, France

Product Family Name: (See Annex: Product List)

Product Class and Rule: (See Annex: Product List)

(1) According to Annex VII of the Council Directive 93/42/EEC concerning Medical Devices, we declare under our
sole responsibility that the distributed CE marked products specified in the annexed product list, meet the
provisions of the Council Directive 93/42/EEC concerning medical devices, which apply to them.

Conformity assessment was performed according to Annex VII.

This declaration is supported by Quality System Certificate for the products concerned. The conformity to quality
assurance set out in the said EN ISO 13485:2012/AC:2012 Conformity Certificate number SX 60104850 0001, issued
and delivered by TUV Rheinland, LGA Products GmbH, Tillystrae 2, 90431 Nuremberg, Germany.

(2) We declare, under our sole responsibility, that the products specified in the annexed product list conform to
the harmonized standard EN 50581, and thereby comply with the RoHS2 Directive, 2011/65/EU. It should be noted
that this statement is applicable to only those part numbers in the annexed product list for which the R0HS2
Directive, 2011/65/EU, is applicable.

Issue date: 2V M-pfri 1 '—/

Signed for and behalf of Stryker Endoscopy by:

Date: Kimberly Lynch

24$-pfr;J
Regulatory Compliance Manager

This declaration is valid until: 01-OCT-2018

DWI1017.01, Rev. B
5900 Optical Court
stryker
San Jose, CA 95138
t: 408 754 2000 f: 408 754 2505
www.stryker.com

Annex - Product List

This product list belongs to the Declaration of Conformity identified by Stryker Endoscopy and specifies
the CE marked products concerned that Stryker Endoscopy intends to distribute in conformity with the
provisions of Council Directive 93/42/EEC concerning medical devices and Council Directive 2011/65/EU
concerning electrical and electronic equipment.

The following list identifies the products by Catalogue number and type.
Product Family Name: Endoscopic Light Source and Accessories and Medical Video Systems and Coupler

Catalogue Product Name Product Class and

NumSer Ru
Stryker, ACM I, Zimm L1H 'p LIass I Rule 1
Wolf, Dyonics Scope AdH Class 1 Rule 1
H •5 Stryker, A.CMI, H.Smm( 1. H H H P (for Styker CH J. Rule 1
Spine)

DWI1017.01, Rev. B