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JOLLY 4 Plus
EUDAMEDClass IIb (EU MDR)
Ref BM6000; BM6010Model JOLLY Plus Series, Joker Plus Series, JET Series, Motion Mobile X-ray System
Identity
- Trade Name
- JOLLY 4 Plus EUDAMED
- Device Name
- Mobile radiologic units EUDAMED
- Model / Reference
- JOLLY Plus Series, Joker Plus Series, JET Series, Motion Mobile X-ray System EUDAMEDBM6000; BM6010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B705JOLLY4PLUS0X EUDAMED
- Basic UDI-DI
- ++B705MOBILEXR EUDAMED
- Direct Marketing DI
- +B705JOLLY4PLUS0X 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
JOLLY 4 Plus 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 | ++B705MOBILEXR | Class IIb | Active |
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Manufacturer
- Manufacturer
- BMI Biomedical International S.r.l.
- EUDAMED SRN
- IT-MF-000017897
Sources (2)
- EUDAMED abfc0de6-3702-41d9-a9ee-97e9c686a11d-1 61 fields · synced Jul 21, 2026
- EUDAMED abfc0de6-3702-41d9-a9ee-97e9c686a11d-2 61 fields · synced Jul 21, 2026