Identity
- Trade Name
- Repose Mattress Overlay FDA UDI
- Generic Name
- Air-filled bed mattress overlay FDA UDI
- Device Name
- Repose Mattress Overlay is designed for use on a standard single mattress, where it is proven to provide effective pressure redistribution. Suitable for use in both acute and community settings, Repose Mattress Overlay comes packaged inside a unique and easy to use pump, which enables the mattress overlay to be inflated ready for use within seconds, and the smart valve ensures that the product is inflated to the optimal pressure. FDA UDI
- Model / Reference
- Repose EUDAMED6011100 EUDAMEDFDA UDI
- Description
- Repose Mattress Overlay is designed for use on a standard single mattress, where it is proven to provide effective pressure redistribution. Suitable for use in both acute and community settings, Repose Mattress Overlay comes packaged inside a unique and easy to use pump, which enables the mattress overlay to be inflated ready for use within seconds, and the smart valve ensures that the product is inflated to the optimal pressure. FDA UDI
Identifiers
- Catalog Number
- 6011100 FDA UDI
- Primary DI / UDI-DI
- 05056279301152 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
6011100 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 1ad1e55a-4851-4726-9890-8f730bae1148 61 fields · synced Jul 24, 2026
- FDA UDI cc07a1d9-27a1-44d9-8179-295c2d500b06 34 fields · synced May 30, 2026