Identity
- Trade Name
- BCA CS EUDAMED
- Device Name
- BCA CS; BCA CR; BCA S; BCA R EUDAMED
- Model / Reference
- BCA CS; BCA CR; BCA S; BCA R EUDAMEDBCACS3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B705BCACS08 EUDAMED
- Basic UDI-DI
- ++B705CARM9B EUDAMED
- Direct Marketing DI
- +B705BCACS08 EUDAMED
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Bca Cs by BMI Biomedical International S.r.l. — Class IIb — 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 | ++B705CARM9B | Class IIb | Active |
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Manufacturer
- Manufacturer
- BMI Biomedical International S.r.l.
- EUDAMED SRN
- IT-MF-000017897
Sources (1)
- EUDAMED 4aa45e2e-b0db-4de1-86c8-bd068743ef4e 61 fields · synced Jul 15, 2026