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Hollister

by Hollister Incorporated United States EUDAMEDGUDID

Ref 3799

Product code EXBEMDN A10020202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D01P068S0178C4 Basic UDI-DIDate2 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00610075128259 UDI-DIDate1 Dec 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Hollister EUDAMED
Pouchkins GUDID
Generic Name
Multiple-piece intestinal ostomy bag, open-ended, single-use
Device Name
2-Piece Drainable Ostomy Pouch
Model / Ref / Catalog
3799
Primary DI / UDI-DI
00610075128259 EUDAMED
00610075110537 GUDID
Basic UDI-DI
610075D01P068S0178C4
Unit of Use DI
00610075083381
FDA Product Code
EXB
EMDN Code
A10020202 Colostomy bags for two-part systems, with tissue cover
GMDN Term
Multiple-piece intestinal ostomy bag, open-ended, single-use
Device Class
Class I
Regulation Number
876.5900
Market of Registration
Ireland
Commercial Distribution
In Commercial Distribution
Size
Lumen/Inner Diameter — 44 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00610075128259
GUDID
00610075110537

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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 7a26303f-6eec-4419-a000-7461fe234bce 61 fields · synced 22 Oct 2026
  • FDA UDI e4a556a9-7fd9-4612-baec-d85f5c5ada4e 36 fields · synced 30 May 2026