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Table Top Accessory Elekta
EUDAMEDClass I (EU MDR)
Ref 11-215Model Table Top Accessory Elekta
Identity
- Trade Name
- Table Top Accessory Elekta EUDAMED
- Device Name
- Oblique Treatment Panel with Inserts EUDAMED
- Model / Reference
- Table Top Accessory Elekta EUDAMED11-215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365112150 EUDAMED
- Basic UDI-DI
- ++B36511213E8 EUDAMED
- Direct Marketing DI
- +B365112150 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
Table Top Accessory Elekta 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 | ++B36511213E8 | 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 eea19f0b-35fd-46b6-b539-fa9d33c28e14 61 fields · synced Oct 6, 2026