Identity
- Trade Name
- PinPoint Accessory EUDAMED
- Device Name
- Carbon Fiber Base Board, Long EUDAMED
- Model / Reference
- PinPoint Accessory EUDAMED50-255 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365502550 EUDAMED
- Basic UDI-DI
- ++B36550100ACCFQ EUDAMED
- Direct Marketing DI
- +B365502550 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
PinPoint Accessory by Aktina Medical Corp — Class I — CE/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 | ++B36550100ACCFQ | 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 884ce14c-bc55-483a-9b38-cdb1cf5b7955 61 fields · synced Oct 6, 2026