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Hollister

by Hollister Incorporated EUDAMEDGUDID

Active European Union

Ref 9811

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D03P016S02329U Basic UDI-DIDate15 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00610075157983 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  • Withdrawn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 25 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Penis wearable urinal
Model / Ref / Catalog
9811
Primary DI / UDI-DI
00610075157983 EUDAMED
00610075055975 GUDID
Basic UDI-DI
610075D03P016S02329U
Unit of Use DI
00610075081097
FDA Product Code
NOA
EMDN Code
A06030301 Urine collection bags
GMDN Term
Penis wearable urinal
Device Class
Class I
Regulation Number
876.5250
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Length — 19 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00610075157983
GUDID
00610075055975

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