Identity
- Trade Name
- PInPoint System EUDAMED
- Device Name
- Vacuum Fixation Mouthpiece, Small (10 pack) EUDAMED
- Model / Reference
- PInPoint System EUDAMED50-470 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365504701 EUDAMED
- Basic UDI-DI
- ++B365505XXPinPointSys6J EUDAMED
- Direct Marketing DI
- +B365504701 EUDAMED
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
Classification
- Device Class
- Class IIa 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 System by Aktina Medical Corp — Class IIa — 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 | ++B365505XXPinPointSys6J | Class IIa | 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 db2df3f4-5324-49dd-aed6-633bac7d6a09 61 fields · synced Oct 6, 2026