Identity
- Trade Name
- BHT-F EUDAMED
- Device Name
- Fixed equipment for radiography EUDAMED
- Model / Reference
- BHE-C; BHE-F; BHT-C; BHT-F EUDAMEDBHTF001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B705BHTF07 EUDAMED
- Basic UDI-DI
- ++B705RADSYSTEMKP EUDAMED
- Direct Marketing DI
- +B705BHTF07 EUDAMED
- EMDN Code
- Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY 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
Category: Stationary basic diagnostic x-ray system, analogue
Bht-F by BMI Biomedical International S.r.l. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++B705RADSYSTEMKP | Class IIb | Active |
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Manufacturer
- Manufacturer
- BMI Biomedical International S.r.l.
- EUDAMED SRN
- IT-MF-000017897
Sources (1)
- EUDAMED 286cb547-532a-4d24-aada-4ecb84852770 61 fields · synced Jun 19, 2026