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Hollister 5551

by Hollister Incorporated EUDAMEDGUDID

Active European Union

Ref 5551

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D01P016S00347U Basic UDI-DIDate9 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00610075072002 UDI-DIDate1 Dec 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Hollister
Generic Name
Ostomy bag extension
Model / Ref / Catalog
5551
Primary DI / UDI-DI
00610075072002 EUDAMED
00610075071999 GUDID
Basic UDI-DI
610075D01P016S00347U
Unit of Use DI
00610075090754
FDA Product Code
EXB
EMDN Code
A060301 Collection bags and other containers for drainages and fistulas, single use
GMDN Term
Ostomy bag extension
Device Class
Class I
Regulation Number
876.5900
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 2000 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00610075072002
GUDID
00610075071999

Other devices from Hollister Incorporated

See all devices from Hollister Incorporated →

Properties

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

Other properties (20)

  • Sterile: No
  • Single Use: 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