Identity
- Trade Name
- Headrest Covers EUDAMEDNon-Woven Headrest covers FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Plastic Headrest covers, Jumbo, 9.5 in X 14 in, White FDA UDI
- Model / Reference
- Barrier Covers EUDAMEDL3CPW EUDAMEDFDA UDI
- Description
- Plastic Headrest covers, Jumbo, 9.5 in X 14 in, White FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10732224002535 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224Cover63 EUDAMED
- Unit of Use DI
- 00732224002538 EUDAMED
- FDA Product Code
- KME FDA UDI
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6060 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Headrest Covers by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0732224Cover63 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 02d3f4cd-10fa-41ba-af6a-3bf48269186f 61 fields · synced Jun 8, 2026
- FDA UDI 663562d6-aa84-4037-b4ad-a54b461261cc 34 fields · synced May 30, 2026