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Open Air Graticule
EUDAMEDClass I (EU MDR)
Ref 11-346Model Open Air GraticuleRef 11-346-M1Ref 11-346-C1
Identity
- Trade Name
- Open Air Graticule EUDAMED
- Device Name
- Open Air Graticule, 2cm EUDAMED
- Model / Reference
- Open Air Graticule EUDAMED11-346 EUDAMED11-346-M1 EUDAMED11-346-C1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365113460 EUDAMED+B36511346M10 EUDAMED+B36511346C10 EUDAMED
- Basic UDI-DI
- ++B36511346OAGKM EUDAMED
- Direct Marketing DI
- +B365113460 EUDAMED+B36511346M10 EUDAMED+B36511346C10 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
Open Air Graticule 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 | ++B36511346OAGKM | 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 (3)
- EUDAMED b163997d-6ac3-45f3-b699-594a79d911e2 61 fields · synced Oct 6, 2026
- EUDAMED c668bdd5-e635-44dd-9862-dc2845ec8964 61 fields · synced May 18, 2026
- EUDAMED 0b8ccee4-b66a-44d6-bc72-ac431e69eb6a 61 fields · synced May 19, 2026