Identity
- Trade Name
- Repose Contur Cover FDA UDI
- Generic Name
- Air-filled chair cushion FDA UDI
- Device Name
- Repose Contur Cover FDA UDI
- Model / Reference
- Repose EUDAMED6310000 EUDAMEDFDA UDI
- Description
- Repose Contur Cover FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056279300940 EUDAMEDFDA UDI
- Basic UDI-DI
- 50562793ReposeGN EUDAMED
- FDA Product Code
- FMW FDA UDI
- EMDN Code
- V08030102 NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS EUDAMED
- GMDN Term
- Air-filled chair cushion FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6190 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
6310000 by Frontier Therapeutics Limited — 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 | 50562793ReposeGN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Frontier Therapeutics Limited
- EUDAMED SRN
- GB-MF-000035429
- Authorised Representative
- Frontier Medical Germany GmbH DE-AR-000031721
Sources (2)
- EUDAMED 6a60064a-045a-4867-9014-6ff54ed5a4b4 61 fields · synced Jul 27, 2026
- FDA UDI 35fddf83-fcc0-4282-8c5d-3dd908594eb5 33 fields · synced May 30, 2026