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Halyard 89821

by O&M Halyard Inc.

Part of a family of 7 devices: see the family page

Ref 89821

Halyard 89821 is a device classified as Class I in the EU and Class II in the US made by O&M Halyard Inc., registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 06806517SP002F2) and listed in FDA GUDID since 15 Mar 2017 (UDI-DI 10680651898217), active as of 23 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number06806517SP002F2 Basic UDI-DI 10680651898217UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10680651898217 UDI-DI Date15 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 06806517SP002F2 registered 2 Sep 2026 Active
  • FDA GUDID UDI-DI 10680651898217 listed 15 Mar 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10680651898217
  2. Registered EUDAMED 06806517SP002F2

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  • Withdrawn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
Patient surgical drape, single-use
Device name
Surgical Accessories sterile
Model / reference
89821
Primary DI / UDI-DI
10680651898217
Basic UDI-DI
06806517SP002F2
FDA product code
KKX
EMDN code
T030199 Covers, instruments and equipment - other
GMDN term
Patient surgical drape, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4370
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Patient surgical drape, single-use

Similar devices in this category

Other devices filed under COVERS, INSTRUMENTS AND EQUIPMENT - OTHER.

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

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