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PositionPro Component
EUDAMEDClass I (EU MDR)
Ref 50-855Model PositionPro Component
Identity
- Trade Name
- PositionPro Component EUDAMED
- Device Name
- PositionPro Cranial Head Support EUDAMED
- Model / Reference
- PositionPro Component EUDAMED50-855 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365508550 EUDAMED
- Basic UDI-DI
- ++B365508XXPosProCompB2 EUDAMED
- Direct Marketing DI
- +B365508550 EUDAMED
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
PositionPro Component by Aktina Medical Corp — 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 | ++B365508XXPosProCompB2 | Class I | Active |
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Manufacturer
- Manufacturer
- Aktina Medical Corp
- EUDAMED SRN
- US-MF-000005935
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 4c3b141f-f1a7-48d9-9c69-eae244936df7 61 fields · synced Jun 19, 2026