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PROS-Wedge w/o Tail
EUDAMEDFDA UDIClass I (EU MDR)
Ref PROS-WEDGEModel Positioning Device
Identity
- Trade Name
- PROS-Wedge w/o Tail EUDAMEDPROS Wedge FDA UDI
- Generic Name
- Freestanding patient positioner, single-use FDA UDI
- Device Name
- PROS Wedge FDA UDI
- Model / Reference
- Positioning Device EUDAMEDPROS-WEDGE EUDAMEDFDA UDI
- Description
- PROS Wedge FDA UDI
Identifiers
- Catalog Number
- PROS-WEDGE FDA UDI
- Primary DI / UDI-DI
- 00816299012729 EUDAMEDFDA UDI
- Basic UDI-DI
- 081629901PWTZ EUDAMED
- FDA Product Code
- FMP FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Freestanding patient positioner, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6450 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
PROS-Wedge w/o Tail by Hovertech International — 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 | 081629901PWTZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- HoverTech International
- EUDAMED SRN
- US-MF-000008435
- Authorised Representative
- Etac Supply Center AB SE-AR-000001601
Sources (2)
- EUDAMED e2f63131-98c4-4626-b1f3-bcd916a8672a 61 fields · synced Jun 19, 2026
- FDA UDI c19adf01-c693-4d56-9942-7f281ccc1061 35 fields · synced May 30, 2026