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Hollister

by Hollister Incorporated EUDAMEDGUDID

Active European Union

Ref 3184

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D01P038S00379W Basic UDI-DIDate20 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05390166003720 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  • Withdrawn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

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
One-piece intestinal ostomy bag, closed-ended
Device Name
1-Piece Closed Ostomy Pouch, Softflex
Model / Ref / Catalog
3184
Primary DI / UDI-DI
05390166003720 EUDAMED
00610075031849 GUDID
Basic UDI-DI
610075D01P038S00379W
Unit of Use DI
00610075077830
FDA Product Code
EXB
EMDN Code
A1001010102 One-piece colostomy bags for non-retracted stoma, flat, with tissue cover
GMDN Term
One-piece intestinal ostomy bag, closed-ended
Device Class
Class I
Regulation Number
876.5900
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 51 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05390166003720
GUDID
00610075031849

Manufacturer details

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

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