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Small Field Collimator, Elekta
EUDAMEDClass I (EU MDR)
Ref 50-302-280Model Circular Small Field Collimators Elekta Integrated
Identity
- Trade Name
- Small Field Collimator, Elekta EUDAMED
- Device Name
- Cone Adapter EUDAMED
- Model / Reference
- Circular Small Field Collimators Elekta Integrated EUDAMED50-302-280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365503022800 EUDAMED
- Basic UDI-DI
- ++B36550370FW EUDAMED
- Direct Marketing DI
- +B365503022800 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
Small Field Collimator, Elekta by Aktina Medical Corp — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Elekta Small Field Circular Cones
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 | ++B36550370FW | 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 9fc39dd6-274d-49f5-be39-bb712bc34632 61 fields · synced May 23, 2026