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PInPoint System
EUDAMEDClass IIa (EU MDR)
Ref 50-510Model PInPoint SystemRef 50-455Ref 50-500Ref 50-501Ref 50-465
Identity
- Trade Name
- PInPoint System EUDAMED
- Device Name
- Vacuum Fixation Mouthpiece, Small (10 pack) EUDAMED
- Model / Reference
- PInPoint System EUDAMED50-510 EUDAMED50-455 EUDAMED50-500 EUDAMED50-501 EUDAMED50-465 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365505100 EUDAMED+B365504551 EUDAMED+B365505000 EUDAMED+B365505010 EUDAMED+B365504651 EUDAMED
- Basic UDI-DI
- ++B365505XXPinPointSys6J EUDAMED
- Direct Marketing DI
- +B365505100 EUDAMED+B365504551 EUDAMED+B365505000 EUDAMED+B365505010 EUDAMED+B365504651 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 (5)
- EUDAMED 7f87be45-00fa-47c7-a68d-aa21cb204082 61 fields · synced Oct 6, 2026
- EUDAMED 83dcef62-9c21-48de-9dc8-3569ae93d8a0 61 fields · synced May 17, 2026
- EUDAMED 50e4386a-fd0c-4147-86d4-d31a0ede3307 61 fields · synced May 18, 2026
- EUDAMED d22aa7bc-2406-43a9-8156-bd11d8f68346 61 fields · synced May 18, 2026
- EUDAMED 6f6a1432-efbe-42cd-b671-65c70885989a 61 fields · synced May 18, 2026