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Headrest Covers

by Crosstex International Inc EUDAMEDGUDID

Active European Union

Ref L0CPModel Barrier Covers

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0732224Cover63 Basic UDI-DIDate29 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10732224002573 UDI-DIDate19 Aug 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Headrest Covers EUDAMED
Plastic Headrest covers GUDID
Generic Name
Medical equipment/instrument drape, single-use
Model / Reference
Barrier Covers, L0CP
Primary DI / UDI-DI
10732224002573
Basic UDI-DI
0732224Cover63
Unit of Use DI
00732224002576
FDA Product Code
KME
EMDN Code
T030199 Covers, instruments and equipment - other
GMDN Term
Medical equipment/instrument drape, single-use
Device Class
Class I
Regulation Number
880.6060
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000009642
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Crosstex International, Inc.

See all devices from Crosstex International, 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