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Breast Board
EUDAMEDClass I (EU MDR)
Ref 11-231Model Breast BoardRef 11-220-05Ref 11-230Ref 11-229
Identity
- Trade Name
- Breast Board EUDAMED
- Device Name
- Breast Board EUDAMED
- Model / Reference
- Breast Board EUDAMED11-231 EUDAMED11-220-05 EUDAMED11-230 EUDAMED11-229 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365112310 EUDAMED+B3651122005 EUDAMED+B365112300 EUDAMED+B365112290 EUDAMED
- Basic UDI-DI
- ++B36511229EP EUDAMED
- Direct Marketing DI
- +B365112310 EUDAMED+B3651122005 EUDAMED+B365112300 EUDAMED+B365112290 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
Breast Board by Aktina Medical Corp — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Tilt Boards
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 | ++B36511229EP | 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 (4)
- EUDAMED 70f01fa9-01f0-4912-b08c-24eec2f5fe8b 61 fields · synced Oct 6, 2026
- EUDAMED 014bb42f-a319-42ab-a728-8026d673b7a8 61 fields · synced May 17, 2026
- EUDAMED 5071b860-2d38-44f0-9e47-d260911a08f2 61 fields · synced May 18, 2026
- EUDAMED 8b1419aa-eef8-428d-817c-20cc4f8116e9 61 fields · synced May 18, 2026