Hollister - Certificacion

Hollister Incorporated Telephone: 847-680-1000
2000 Hollister Drive Facsimile: 847-918-3981

Libertyville, IL 60048-3781 Web site: www.hollister.com
Declaration of Conformity
Hollister Incorporated hereby declares that the below mentioned medical devices—
(i) Comply with all the requirements under Decree 36 of the Vietnam Government;
(ii) Have been classified according to the classification rules as specified in Article 4 of Decree 36,
(iii) Conform to the requirements of Decree 36.
(A) PARTICULARS OF MEDICAL DEVICE
Non-Sterile Continence
Medical Device
Country GMDN Registration Manufacturing
SKU Product Classification
of Origin Codes Number/Approval Site
Code
Hollister
9823, Drainable Fecal Class *US Incorporated
USA 47038
9880 Collector A *EU Stuarts Draft,
VA
97525,
Inview Standard
97529, Davol Surgical
Silicone Self- Class
97532, Mexico 34929 *US Innovations
Adhesive A
97536, Juarez, Mexico
Catheter
97541
InView Special
97425, Davol Surgical
Silicone Self- Class
97429, Mexico 34929 *US Innovations
Adhesive A
97432 Juarez, Mexico
Catheter
Sterile Critical Care

Medical Device
Country
GMDN Registration Manufacturing
SKU Product of Classification
Codes Number/Approval Site
Origin
Code
Horizontal
Drain/Tube
Attachment Hollister
NSAI Quality
9781, Device Class Incorporated
USA 56631 System Approval
9782 Vertical A Stuarts Draft,
Certificate 252.242
Drain/Tube VA
Attachment
Device
Non-Sterile Critical Care

Medical Device
Country
Origin
Code
AnchorFast Hollister
Guard Oral Class *US Incorporated
9800 USA 35815
Endotracheal A *EU Stuarts Draft,
Tube Fastener VA
Hollister
AnchorFast Oral
Class *US Incorporated
9799 Endotracheal USA 35815
A *EU Stuarts Draft,
Tube Fastener
VA
AnchorFast
Hollister
SlimFit
9787 Oral USA 35815
Endotracheal
VA
Tube Fastener
AnchorFast
Hollister
Guard Select
9700 Oral USA 35815
Endotracheal
VA
Tube Fastener
Hollister
AnchorFast
9788 Replacement USA 35815
Neck Straps
VA
Seisa Medical
Feeding Tube
Class US Inc. SEI
9786 Attachment Mexico 36053
A *EU Medical SA. De
Device
C.V. Juarez
Non-Sterile Ostomy
Medical Device
Country
Origin
Code
56900,
56901, Hollister
56920, Moderma Flex Class Incorporated
USA 31075 *EU
56925, Drainable Pouch A Stuarts Draft,
56930, VA
56935
Hollister
Moderma Flex High
Class Incorporated
26064 Output Drainable USA 31075 *EU
A Stuarts Draft,
Pouch
VA
Hollister
18372,
New Image Closed Class Incorporated
18373, USA 31067 *US
Pouch A Stuarts Draft,
18374
VA
18006,
18102,
18103,
18104,
18122,
18123,
18124, Hollister
18132, New Image Class Incorporated
USA 31076 *US
18133, Drainable Pouch A Stuarts Draft,
18134, VA
18182,
18183,
18184,
18192,
18193,
18194
Hollister
18012, New Image High
Class Incorporated
18013, Output Drainable USA 31076 *US
A Stuarts Draft,
18014 Pouch
VA
Hollister
New Image
18202, Class Incorporated
Drainable Mini- USA 31076 *US
18203 A Stuarts Draft,
Pouch
VA
Medical Device
Country
Origin
Code
14703,
14704,
14705,
14707,
14102,
14103,
14104,
Hollister
14202,
New Image Skin Class Incorporated
14203, USA 48159 *US
Barrier - Flat A Stuarts Draft,
14204,
VA
14602,
14603,
14604,
14606,
15602,
15603,
15604
14802,
14803,
14804,
14903,
14904,
Hollister
14905,
New Image Skin Class Incorporated
14906, USA 48158 *US
Barrier - Convex A Stuarts Draft,
14907,
VA
14908,
14909,
15802,
15803,
15804
18402,
18403, Hollister
18404, New Image Class Incorporated
USA 31069 *US
18922, Urostomy Pouch A Stuarts Draft,
18923, VA
18924
Hollister
Pouchkins Drainable Class *US Incorporated
3796 USA 31075
Pouch – Infant A *EU Stuarts Draft,
VA
Hollister
Pouchkins Newborn Class *US
3778 USA 31075 Incorporated
Ostomy Pouch A *EU
Kirksville, MO
Hollister
Pouchkins Premie Class *US
Ostomy Pouch A *EU
Kirksville, MO
Medical Device
Country
Origin
Code
Hollister
Pouchkins Urostomy Class *US Incorporated
3797 USA 64584
Pouch - Infant A *EU Stuarts Draft,
VA
82300, Premier Closed Class Hollister ULC

Ireland 31066 *US
82400 Pouch A Ballina
8181,
8331,
8511,
8512,
8513,
8514,
8515,
85116,
85211,
8524,
8528,
8531,
8551,
8591,
8592, Hollister
8593, Premier Drainable Class Incorporated
USA 31075 *US
8594, Pouch A Stuarts Draft,
8595, VA
8596,
8610,
8611,
8612,
8613,
8614,
8615,
8616,
8624,
8628,
86211,
8631,
8651,
88400
Premier Drainable Class Hollister ULC
88800 Ireland 31075 *US
Mini-Pouch A Ballina
8460,
8462,
8474,
8478, Hollister
84711, Premier Urostomy Class Incorporated
USA 64584 *US
8483, VA
8484,
8485,
8486,
Medical Device
Country
Origin
Code
8487,
84590
Hollister
7610, Suavita Drainable Class Incorporated
USA 31075 *US
7620 Pouch A Stuarts Draft,
VA
Hollister
45541, Class Incorporated
Suavita Skin Barrier USA 48159 *US
47541 A Stuarts Draft,
VA
45603,
45604,
45703, Hollister
45704, Suavita Drainable Class Incorporated
USA 31076 *US
47604, VA
47703,
47704
Non-Sterile Wound Care

Medical Device
Code
Hollister
9773,
Wound Drainage Class *US Incorporated
9776, USA 11301
Collector A *EU Stuarts Draft,
9778
VA
Sterile Wound Care

Medical Device
Code
Hollister
9701, Wound Drainage NSAI Quality
Class Incorporated
9702, Collector with USA 62805 System Approval
A Stuarts Draft,
9703 Barrier Certificate 252.242
VA
Hollister
Wound Drainage NSAI Quality
Class Incorporated
9775 Collector without USA 62805 System Approval
A Stuarts Draft,
Barrier Certificate 252.242
VA
Non-Sterile Ostomy Accessories

Medical Device
Country GMDN Classificati Registration Manufacturing
SKU Product
of Origin Codes on Number/Approval Site
Code
Seisa Medical
7299, Class *US Inc. SEI Medical
Adapt Belt Mexico 42452
7300 A *EU SA. De C.V.
Juarez
Hollister
Adapt Lubricating Class *US Incorporated
78500 USA 37592
Deodorant A *EU Stuarts Draft,
VA
AndersonBrecon
Adapt Lubricating Class *US
78501 USA 37592 Packaging Inc.
Deodorant A *EU
Rockford, IL
Aurena
Adapt Medical Class *US Laboratories AB
7730 USA 10035
Adhesive A *EU Karlstad,
Sweden
Hollister
Adapt Stoma Class *US Incorporated
7740 USA 33587
Lubricant A *EU Stuarts Draft,
VA
Hollister
Drainable Pouch Class *US
Clamp A *EU
Kirksville, MO
Hollister
Odor Eliminator Class Incorporated
7733 USA 37592 *US
Spray Unscented A Stuarts Draft,
VA
Premier Stoma Class Dasnac A/S
1796 Denmark 31073 *US
Cap A Fredensborg
Huida
Biopharmaceutic
Adapt Skin Class *US
7917 USA 46206 als (Suzhou)
Protective Wipes A *EU
Ltd., Suzhou
City, China
Acupac
Adapt Universal Class *US Packaging Inc.
7760 USA 60494
Remover Wipes A *EU Mahwah, New
Jersey
Hollister
Urostomy Drain Class *US
Tube Adapter A *EU
Kirksville, MO
Hollister
7805, Adapt Barrier Class *US Incorporated
USA 46207
7806 Rings A *EU Stuarts Draft,
VA
79520,
79530, Hollister
79540, Adapt Convex Class *US Incorporated
USA 46207
79601, Barrier Rings A *EU Stuarts Draft,
79602, VA
79603
Adapt Medical Aurena
Class *US
7737 Adhesive Sweden 60494 Laboratories, AB
A *EU
Remover Karlstad
Hollister
79300, Class *US Incorporated
Adapt Paste USA 46207
79301 A *EU Stuarts Draft,
VA
Biomed
Adapt Stoma Class *US Laboratories,
7906 USA 46206
Powder A *EU LLC
Dallas TX
Hollister
7905 Karaya 5 Powder USA 46206
VA
Hollister
Flextend Skin Class Incorporated
8800 USA 46207 *US
Barrier A Stuarts Draft,
VA
Hollister
Restore Skin
Class Incorporated
517220 Conditioning USA 46206 *US
A Stuarts Draft,
Crème
VA
Non-Sterile Ostomy Irrigation

Medical Device
Code
Hollister Medical
18152, New Image
Class India Private
18153, Drainable USA 37716 *US
A Limited
18154 Irrigator Sleeve
Bawa, India
Hollister Medical
Stoma Cone Class India Private
7721 USA 37716 *US
Irrigator Kit A Limited
Bawa, India
Hollister Medical
Stoma Cone with Class *US India Private
7723 USA 37716
Connector A *EU Limited
Bawa, India
Hollister Medical
Stoma Irrigator Class *US India Private
7728 USA 37716
Sleeve A *EU Limited
Bawa, India
Medical Device Registration Number/Approval Code:

*US – These products are exempt from premarket notification per the United States Code of Federal
Regulations Title 21.
*EU – These products are in compliance with Annex VII of the Council Directive 93/42/EEC concerning
medical devices. Hollister Incorporated declares that the Class I medical devices conform to the essential
requirements described in Annex I of the Medical Device Directive.
Risk-based classifications: As per the Article 4 of Decree 36 of the Vietnam Government.

(B) QUALITY MANAGEMENT SYSTEM CERTIFICATE (“QMS”)
Hollister Incorporated – Stuarts Draft

Conformity Assessment Body issuing the certificate: NSAI
Certificate number: MD19.4106/C
Issuance date: Oct. 24, 2019
Expiry date: Sep. 09, 2021
Hollister Incorporated - Kirksville

Certificate number: MD19.4106/E
Hollister ULC - Ballina

Certificate number: MD19.4106/D
Hollister Medical India Private Limited

Certificate number: MD19.4106/F
Acupac Packaging Inc. - Mahwah

Conformity Assessment Body issuing the certificate: BSI
Certificate number: FM 555204
Issuance date: Jan. 26, 2019
Expiry date: Jan. 25, 2022
AndersonBrecon Packaging Inc. – Rockford

Conformity Assessment Body issuing the establishment inspection report: US FDA Report number: 1450819
Aurena Laboratories AB - Karlstad

Conformity Assessment Body issuing the certificate: Intertek
Certificate number: 28874-02
Issuance date: Nov. 20, 2018
Expiry date: Nov. 19, 2021
Biomed Laboratories, LLC – Dallas

Expiry date: Oct. 11, 2022
Dansac A/S - Fredensborg

Certificate number: MD19.4106/G
Davol Surgical Innovations - Juarez

Issuance date: Aug. 27, 2018
Expiry date: Aug. 26, 2021
Huida Biopharmaceuticals (Suzhou) Ltd. - Suzhou City

Conformity Assessment Body issuing the certificate: NSF International Strategic Registrations
Certificate number: CNQMSMD031967
Issuance date: Mar. 15, 2018
Expiry date: Mar. 14, 2021
Seisa Medical Inc. - Juarez

Conformity Assessment Body issuing the certificate: TUV SUD Product Service GmbH
Certificate number: Q5 18 02 38783 012
Issuance date: Mar. 20, 2018
Expiry date: Mar. 19, 2021
LIST OF STANDARDS CURRENTLY IN USE

In support of demonstrating conformity to essential requirements please be advised that the following
standards are currently in use by Hollister Incorporated.
ISO 10993. Biological Evaluation of Medical Devices as applicable:

Applicable Standards Equivalent Standard
EN ISO 10993-1:2009/AC:2010 ISO 10993-1:2009, Cor 1: 2010
EN ISO 10993-3:2014 ISO 10993-3:2014
EN ISO 10993-4:2009 ISO 10993-4:2017
EN ISO 10993-5:2009 ISO 10993-5:2009
EN ISO 10993-7:2008/AC:2009 ISO 10993-7:2008, Cor 1: 2009
EN ISO 10993-10:2013 ISO 10993-10:2010
EN ISO 10993-11:2009 ISO 10993-11:2017
EN ISO 10993-12:2012 ISO 10993-12:2012
EN ISO 10993-17:2009 ISO 10993-17:2002
EN ISO 10993-18:2009 ISO 10993-18:2005
Other Applicable EU Standards
EN 556-1:2001/AC:2006 None
EN 1041:2008+ A1 :2013 None
EN 1616:1997 DIN EN 1616:1997+A1:1999
EN 1618:1997 None
ISO 8670-1:1988 None
EN ISO 8670-2:1997 ISO 8670-2:1996
EN ISO 11135:2014 ISO 11135:2014
EN ISO 11137-1:2006 + A1:2013 ISO 11137-1:2006
EN ISO 11137-2:2015 ISO 11137-2:2013
EN ISO 11138-1:2006 ISO 11138-1:2006
EN ISO 11138-2:2009 ISO 11138-2:2006
EN ISO 11607-1:2009 ISO 11607-1:2006
EN ISO 11607-2:2006 ISO 11607-2:2006
EN ISO 11737-1:2006/AC:2009 ISO 11737-1:2006/Cor 1: 2007
EN ISO 11737-2:2009 ISO 11737-2:2009
EN 13427:2004 None
EN ISO 13485:2012 ISO 13485:2016
EN 13868:2002 None
EN ISO 14155:2011 ISO 14155:2011
EN ISO 14971:2012 ISO 14971:2007
EN ISO 15223-1:2016 ISO 15223-1:2016
EN ISO/IEC 17025:2005 ISO/IEC 17025:2005
EN ISO 22442-1:2015 ISO 22442-1:2015
None ANSI/AAMI/ISO TIR 13004
EN 556-1:2001/AC:2006 None
ISO 10993. Biological Evaluation of Medical Devices as applicable:
Applicable Standards Equivalent Standard
EN ISO 10993-1:2009/AC:2010 ISO 10993-1:2009, Cor 1: 2010
EN ISO 10993-3:2014 ISO 10993-3:2014
EN ISO 10993-4:2009 ISO 10993-4:2017
EN ISO 10993-5:2009 ISO 10993-5:2009
EN ISO 10993-7:2008/AC:2009 ISO 10993-7:2008, Cor 1: 2009
EN ISO 10993-10:2013 ISO 10993-10:2010

EN ISO 10993-11:2009 ISO 10993-11:2017
EN ISO 10993-12:2012 ISO 10993-12:2012
EN ISO 10993-17:2009 ISO 10993-17:2002
EN ISO 10993-18:2009 ISO 10993-18:2005
Other Applicable EU Standards
EN 556-1:2001/AC:2006 None
EN 1041:2008+ A1 :2013 None
EN 1616:1997 DIN EN 1616:1997+A1:1999
EN 1618:1997 None
ISO 8670-1:1988 None
EN ISO 8670-2:1997 ISO 8670-2:1996
EN ISO 11135:2014 ISO 11135:2014
EN ISO 11137-1:2006 + A1:2013 ISO 11137-1:2006
EN ISO 11137-2:2015 ISO 11137-2:2013
EN ISO 11138-1:2006 ISO 11138-1:2006
EN ISO 11138-2:2009 ISO 11138-2:2006
EN ISO 11607-1:2009 ISO 11607-1:2006
EN ISO 11607-2:2006 ISO 11607-2:2006
EN ISO 11737-1:2006/AC:2009 ISO 11737-1:2006/Cor 1: 2007
EN ISO 11737-2:2009 ISO 11737-2:2009
EN 13427:2004 None
EN ISO 13485:2012 ISO 13485:2016
EN 13868:2002 None
EN ISO 14155:2011 ISO 14155:2011
EN ISO 14971:2012 ISO 14971:2007
EN ISO 15223-1:2016 ISO 15223-1:2016
EN ISO/IEC 17025:2005 ISO/IEC 17025:2005
EN ISO 22442-1:2015 ISO 22442-1:2015
None ANSI/AAMI/ISO TIR 13004
EN 556-1:2001/AC:2006 None
The essential requirements these standards support are outlined below:
21 CFR Part 820 – USA

Council Directive 93/42/EEC – EU
Medical Device Regulations SOR/98-282 – Canada
Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002
– Australia
LIST OF STANDARDS CURRENTLY IN USE

Appendix
The following is a list of data sources used to inform when new standards are issued or current standards are
updated.
1. U.S. Food & Drug Administration Daily Digest Bulletin

2. AAMI Standards Monitor Online (monthly e-publication)
3. International Medical Device Regulatory Monitor (monthly publication)
4. Clinica Medtech Intelligence (monthly publication)
5. BSI eUpdate
6. LNE/G-MED America Newsletter

Hollister - Certificacion

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Hollister Incorporated Telephone: 847-680-1000

2000 Hollister Drive Facsimile: 847-918-3981

(A) PARTICULARS OF MEDICAL DEVICE

Sterile Critical Care

Non-Sterile Critical Care

82300, Premier Closed Class Hollister ULC

Non-Sterile Wound Care

Sterile Wound Care

Non-Sterile Ostomy Accessories

Non-Sterile Ostomy Irrigation

Medical Device Registration Number/Approval Code:

Risk-based classifications: As per the Article 4 of Decree 36 of the Vietnam Government.

(B) QUALITY MANAGEMENT SYSTEM CERTIFICATE (“QMS”)

Hollister Incorporated – Stuarts Draft

Hollister Incorporated - Kirksville

Hollister ULC - Ballina

Hollister Medical India Private Limited

Acupac Packaging Inc. - Mahwah

AndersonBrecon Packaging Inc. – Rockford

Aurena Laboratories AB - Karlstad

Biomed Laboratories, LLC – Dallas

Dansac A/S - Fredensborg

Davol Surgical Innovations - Juarez

Huida Biopharmaceuticals (Suzhou) Ltd. - Suzhou City

Seisa Medical Inc. - Juarez

LIST OF STANDARDS CURRENTLY IN USE

ISO 10993. Biological Evaluation of Medical Devices as applicable:

EN ISO 10993-10:2013 ISO 10993-10:2010

The essential requirements these standards support are outlined below:

21 CFR Part 820 – USA

LIST OF STANDARDS CURRENTLY IN USE

1. U.S. Food & Drug Administration Daily Digest Bulletin

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