← Back to catalogue
PROS-Wedge XL
EUDAMEDClass I (EU MDR)
Ref PROS-XL-KITModel Positioning DeviceRef PROS-XL-18Ref PROS-XL-20
Identity
- Trade Name
- PROS-Wedge XL EUDAMED
- Model / Reference
- Positioning Device EUDAMEDPROS-XL-KIT EUDAMEDPROS-XL-18 EUDAMEDPROS-XL-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816299012828 EUDAMED00816299012835 EUDAMED00816299012842 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 XL 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HoverTech International
- EUDAMED SRN
- US-MF-000008435
- Authorised Representative
- Etac Supply Center AB SE-AR-000001601
Sources (3)
- EUDAMED c05f509b-30ee-4772-b13a-b7c182447a53 61 fields · synced Aug 2, 2026
- EUDAMED 7a3b9138-80c2-4fed-8bc4-7afcbc76671e 61 fields · synced May 18, 2026
- EUDAMED 2072eece-e2dc-4ad8-99b4-c4e712ac0f8d 61 fields · synced May 18, 2026