Skip to content

Halyard 75641

by O&M Halyard Inc.

Ref 75641

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number06806517AP0018S Basic UDI-DI 20680651756415UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20680651756415 UDI-DI Date16 Nov 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Isolation gown, single-use
Device Name
Apparel
Model / Ref / Catalog
75641
Primary DI / UDI-DI
20680651756415
Basic UDI-DI
06806517AP0018S
FDA Product Code
LYU
EMDN Code
T0205, T0207, T0208, T0299
GMDN Term
Isolation gown, single-use
Device Class
Class I
Regulation Number
878.4040
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Related devices

Category: Isolation gown, single-use

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

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