Identity
- Trade Name
- BCA R EUDAMED
- Device Name
- BCA CS; BCA CR; BCA S; BCA R EUDAMED
- Model / Reference
- BCA CS; BCA CR; BCA S; BCA R EUDAMEDBCAR8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B705BCAR0_ EUDAMED
- Basic UDI-DI
- ++B705CARM9B EUDAMED
- Direct Marketing DI
- +B705BCAR0_ EUDAMED
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES 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 R 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 26da112b-c911-423c-8c1a-020e35c6c3a0 61 fields · synced Jun 19, 2026