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Reusable Foam Positioning Wedge
EUDAMEDClass I (EU MDR)
Ref FPW-R-20SModel Positioning Device
Identity
- Trade Name
- Reusable Foam Positioning Wedge EUDAMED
- Model / Reference
- Positioning Device EUDAMEDFPW-R-20S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816299011418 EUDAMED
- Basic UDI-DI
- 081629901RWU7 EUDAMED
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Reusable Foam Positioning Wedge by Hovertech International — 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 | 081629901RWU7 | Class I | Active |
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Manufacturer
- Manufacturer
- HoverTech International
- EUDAMED SRN
- US-MF-000008435
- Authorised Representative
- Etac Supply Center AB SE-AR-000001601
Sources (1)
- EUDAMED c5290b24-f0f0-42b9-a70c-1bd7228106c5 61 fields · synced Jun 18, 2026