Identity
- Trade Name
- PROS-Wedge Kit EUDAMED
- Model / Reference
- Positioning Device EUDAMEDPROS-W-KIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816299012743 EUDAMED
- Basic UDI-DI
- 081629901PWTZ 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
PROS-Wedge Kit 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 | 081629901PWTZ | 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 eafd5eaf-65d0-4d91-81aa-c40b3e9c5b26 61 fields · synced Jun 18, 2026