Identity
- Trade Name
- Repose Mattress and Pump (Bulk Pack 10) FDA UDI
- Generic Name
- Air-filled bed mattress overlay FDA UDI
- Device Name
- Repose Mattress and Pump (Bulk Pack 10) FDA UDI
- Model / Reference
- Repose EUDAMED6111100 EUDAMED611100 FDA UDI
- Description
- Repose Mattress and Pump (Bulk Pack 10) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056279301428 EUDAMEDFDA UDI
- Basic UDI-DI
- 50562793ReposeGN EUDAMED
- FDA Product Code
- IKY FDA UDI
- EMDN Code
- V080702 NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
- GMDN Term
- Air-filled bed mattress overlay FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5150 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
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
6111100 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 79b14544-8d7d-49de-9233-2a5459cdca38 61 fields · synced Jun 18, 2026
- FDA UDI bf159c4a-3689-4e5b-834a-3f03ec9d0567 34 fields · synced May 30, 2026