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Wedge Filter Elekta
EUDAMEDClass I (EU MDR)
Ref 11-495-15Model Wedge Filter ElektaRef 11-495-60Ref 11-495-30
Identity
- Trade Name
- Wedge Filter Elekta EUDAMED
- Device Name
- Elekta External Wedge Kit - 15 EUDAMED
- Model / Reference
- Wedge Filter Elekta EUDAMED11-495-15 EUDAMED11-495-60 EUDAMED11-495-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B36511495150 EUDAMED+B36511495600 EUDAMED+B36511495300 EUDAMED
- Basic UDI-DI
- ++B365ELEKTAACCBMYX EUDAMED
- Direct Marketing DI
- +B36511495150 EUDAMED+B36511495600 EUDAMED+B36511495300 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
Wedge Filter Elekta by Aktina Medical Corp — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: ABC Mouthpiece Filter Kit
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 | ++B365ELEKTAACCBMYX | 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 f100de0a-5f78-4b51-ae9d-7ab690ff748c 61 fields · synced Oct 6, 2026
- EUDAMED 88109071-0a43-46cf-8213-21bbfc901025 61 fields · synced May 18, 2026
- EUDAMED be18ab87-00a4-491a-9a68-446a746a0885 61 fields · synced May 18, 2026