Identity
- Trade Name
- Prone One EUDAMED
- Device Name
- Prone One EUDAMED
- Model / Reference
- 925.PF-SSP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810075281088 EUDAMED
- Basic UDI-DI
- 081007528925PFSSPSS EUDAMED
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Prone One by Bone Foam, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081007528925PFSSPSS | Class I | Active |
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Manufacturer
- Manufacturer
- Bone Foam, Inc.
- EUDAMED SRN
- US-MF-000035043
- Authorised Representative
- Bone Foam B.V. NL-AR-000035735
Sources (1)
- EUDAMED 845a9b23-7d76-4b19-9a8c-d7f73c4e8c67 61 fields · synced Jun 19, 2026