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Hollister

by Hollister Incorporated EUDAMEDGUDID

Active European Union Open recall

Ref 82104

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D03P090S0173BX Basic UDI-DIDate28 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00610075072484 UDI-DIDate20 May 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  • Withdrawn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

1 recall · 1 ongoing · FDA

    • Ongoing Z-2998-2026 FDA Class II initiated 14 Jul 2026

    Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.

Specification

EUDAMED · GUDID

Trade Name
Hollister EUDAMED
Onli GUDID
Generic Name
Single-administration urethral drainage catheter
Model / Reference
82104
Primary DI / UDI-DI
00610075072484, 00610075072415
Basic UDI-DI
610075D03P090S0173BX
Unit of Use DI
00610075072880
510(k) Number
FDA Product Code
GBM
EMDN Code
U01010501 Nelaton catheters, self-lubricating
GMDN Term
Single-administration urethral drainage catheter
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5130
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Length — 16 Inch
Catheter Gauge — 10 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

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

Related devices

Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use

Other devices from Hollister Incorporated

See all devices from Hollister Incorporated →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No