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Hollister

by Hollister Incorporated EUDAMEDGUDID

Active European Union EUDAMED: not on the EU market

Ref 9349

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D03P094S0348DW Basic UDI-DIDate1 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00610075175598 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  • Withdrawn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 24 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Wearable adult urine collection bag, open-ended
Model / Ref / Catalog
9349
Primary DI / UDI-DI
00610075175598 EUDAMED
00610075093496 GUDID
Basic UDI-DI
610075D03P094S0348DW
FDA Product Code
NNW
EMDN Code
A06030399 Urine collection systems - other
GMDN Term
Wearable adult urine collection bag, open-ended
Device Class
Class I
Regulation Number
876.5250
Medical Purpose
A urinary leg bag collects and contains urine. The extension tubing diverts urine to urinary collection bags. The straps secure a urinary leg bag to the leg. These accessory products are for individuals with urinary incontinence or a urinary stoma.
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 900 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00610075175598
GUDID
00610075093496
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
US-PR-000046534

Other devices from Hollister Incorporated

See all devices from Hollister Incorporated →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Over-the-Counter
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No