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Halyard 41205

by O&M Halyard Inc.

Ref 41205

Halyard 41205 is a Class I device made by O&M Halyard Inc., registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 06806517FP001AH) and listed in FDA GUDID since 17 Mar 2016 (UDI-DI 30680651412059), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number06806517FP001AH Basic UDI-DI 30680651412059UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30680651412059 UDI-DI Date17 Mar 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 06806517FP001AH registered 2 Sep 2026 Active
  • FDA GUDID UDI-DI 30680651412059 listed 17 Mar 2016 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 30680651412059
  2. Registered EUDAMED 06806517FP001AH

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  • Withdrawn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
Face splash shield, single-use
Device name
Facial protection
Model / Ref / Catalog
41205
Primary DI / UDI-DI
30680651412059
Basic UDI-DI
06806517FP001AH
FDA product code
HOY
EMDN code
T020603, T020604, T020699
GMDN term
Face splash shield, single-use
Device class
Class I
Regulation number
886.4750
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS).

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

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