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Halyard 48970

by O&M Halyard Inc.

Part of a family of 162 devices: see the family page

Ref 48970

Halyard 48970 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 26 Aug 2026 (Basic UDI-DI 06806517SD002CE) and listed in FDA GUDID since 16 Nov 2023 (UDI-DI 10680651489705), 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 Number06806517SD002CE Basic UDI-DI 10680651489705UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10680651489705 UDI-DI Date16 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 06806517SD002CE registered 26 Aug 2026 Active
  • FDA GUDID UDI-DI 10680651489705 listed 16 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10680651489705
  2. Registered EUDAMED 06806517SD002CE

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  • Withdrawn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 Drapes Sterile
Model / Ref / Catalog
48970
Primary DI / UDI-DI
10680651489705 EUDAMED
30680651489709 GUDID
Basic UDI-DI
06806517SD002CE
FDA product code
PUI
EMDN code
T020102 Specialistic surgery drapes
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 · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10680651489705
GUDID
30680651489709
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 10680651489705; FDA GUDID lists 30680651489709), so their flags are not compared. 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 SURGICAL DRAPES.

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)