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Hollister

by Hollister Incorporated 117 variants

Ref 9776

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D01P084S0218B5 Basic UDI-DIDate15 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00610075113729 UDI-DIDate21 Sep 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Wound drainage bag
Device Name
Wound Drainage Collectors
Model / Reference
9776
Primary DI / UDI-DI
00610075113729 EUDAMED
00610075097760 GUDID
Basic UDI-DI
610075D01P084S0218B5
Unit of Use DI
00610075072620
FDA Product Code
GDS
EMDN Code
A060301 Collection bags and other containers for drainages and fistulas, single use
GMDN Term
Wound drainage bag
Device Class
Class I
Regulation Number
876.5900
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 9.5 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00610075113729
GUDID
00610075097760

Manufacturer details

EUDAMED SRN
US-MF-000027818
Authorised representative
Hollister ULC IE-AR-000022119

Related devices

Category: Negative-pressure wound therapy system canister

Other devices from Hollister Incorporated

See all devices from Hollister Incorporated →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No