Identity
- Trade Name
- BBV APP EUDAMED
- Device Name
- BBV APP EUDAMED
- Model / Reference
- REF001 EUDAMEDREF 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290019252009 EUDAMED
- Basic UDI-DI
- B-07290019252009 EUDAMED
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bbv App by Black Box Voice Medical Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290019252009 | Class I | Active |
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Manufacturer
- Manufacturer
- Black Box Voice Medical Ltd.
- EUDAMED SRN
- IL-MF-000017084
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 28519335-c91f-4f75-868e-487bb17656bc 61 fields · synced Jun 19, 2026