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Halyard 69551

by O&M Halyard Inc.

Part of a family of 57 devices: see the family page

Ref 69551

Halyard 69551 is a Class I device made by O&M Halyard Inc., registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 06806517AP0018S) and listed in FDA GUDID since 16 Nov 2020 (UDI-DI 20680651695516), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number06806517AP0018S Basic UDI-DI 20680651695516UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20680651695516 UDI-DI Date16 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 06806517AP0018S registered 2 Sep 2026 Active
  • FDA GUDID UDI-DI 20680651695516 listed 16 Nov 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 20680651695516
  2. Registered EUDAMED 06806517AP0018S

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Halyard
Generic name
Shoe cover
Device name
Apparel
Model / Ref / Catalog
69551
Primary DI / UDI-DI
20680651695516
Basic UDI-DI
06806517AP0018S
FDA product code
FXP
EMDN code
T0205, T0207, T0208, T0299
GMDN term
Shoe cover
Device class
Class I
Regulation number
878.4040
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Related devices

Category: Shoe cover

Similar devices in this category

Other devices filed under NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE).

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)