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b-box plus (DANAI)
EUDAMEDClass IIa (EU MDR)
Ref b-box plus(DANAI)
by b-rayZ AG
Identity
- Device Name
- b-box plus (DANAI) EUDAMED
- Model / Reference
- b-box plus(DANAI) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649991532034 EUDAMED
- Basic UDI-DI
- 7649991532bboxplus2xxEU EUDAMED
- Direct Marketing DI
- 07649991532034 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
b-box plus (DANAI) by b-rayZ AG — Class IIa — 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 | 7649991532bboxplus2xxEU | Class IIa | Active |
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Manufacturer
- Manufacturer
- b-rayZ AG
- EUDAMED SRN
- CH-MF-000020036
- Authorised Representative
- MED-RAS GmbH Regulatory Affairs Service DE-AR-000006211
Sources (1)
- EUDAMED 130fae0e-ebb0-4109-8792-d37e432cd035 61 fields · synced Jun 18, 2026