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Port Film Graticule Elekta
EUDAMEDClass I (EU MDR)
Ref 11-344Model Port Film Graticule Elekta
Identity
- Trade Name
- Port Film Graticule Elekta EUDAMED
- Device Name
- Port Film Graticule EUDAMED
- Model / Reference
- Port Film Graticule Elekta EUDAMED11-344 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365113440 EUDAMED
- Basic UDI-DI
- ++B36511344PFGKT EUDAMED
- Direct Marketing DI
- +B365113440 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Port Film Graticule Elekta by Aktina Medical Corp — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Mouthpiece Support Options
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 | ++B36511344PFGKT | 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 82270fe1-969a-48e7-8ad3-fb1ce6681ae6 61 fields · synced May 22, 2026