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Hollister

by Hollister Incorporated 117 variants

Ref 70142

Hollister (70142) is a device classified as Class I in the EU and Class II in the US made by Hollister Incorporated, registered in EUDAMED on 28 Apr 2025 (Basic UDI-DI 610075D03P080S0261BC), cleared under FDA 510(k) K143594 on 9 Jan 2015 and listed in FDA GUDID since 30 Sep 2022 (UDI-DI 00610075052981), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143594

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D03P080S0261BC Basic UDI-DI 00610075052981UDI-DIDate28 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00610075052981 UDI-DI Date30 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK143594 Date9 Jan 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 610075D03P080S0261BC registered 28 Apr 2025 Active
  • FDA 510(k) K143594 decided 9 Jan 2015 Active
  • FDA GUDID UDI-DI 00610075052981 listed 30 Sep 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K143594
  2. Listed FDA GUDID 00610075052981
  3. Registered EUDAMED 610075D03P080S0261BC

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Hollister EUDAMED
VaPro Pocket GUDID
Generic name
Single-administration urethral drainage catheter
Device name
No Touch Urethral Intermittent Catheter, Nelaton, 20cm
Model / reference
70142 EUDAMED
70142-30 GUDID
Primary DI / UDI-DI
00610075052981
Basic UDI-DI
610075D03P080S0261BC
Unit of use DI
00610075087754
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
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 14 French
Length — 8 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
70142
GUDID
70142-30
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Similar devices in this category

Other devices filed under URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON.

Other devices from Hollister Incorporated

See all devices from Hollister Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)