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Halyard 49049

by O&M Halyard Inc.

Ref 49049

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number06806517SD002CE Basic UDI-DI 10680651490497UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10680651490497 UDI-DI Date17 Aug 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
49049
Primary DI / UDI-DI
10680651490497 EUDAMED
30680651490491 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 market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10680651490497
GUDID
30680651490491
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Patient surgical drape, single-use

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Manufacturing Date: No