Identity
- Device Name
- Medical Alarm System EUDAMED
- Model / Reference
- BF-MGA EUDAMED06979329811021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979329811021 EUDAMED
- Basic UDI-DI
- 697932981BFMGAR4 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Medical Alarm System by Blackfish Industries(Shanghai) Co., Ltd. — Class I — 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 | 697932981BFMGAR4 | Class I | Active |
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Manufacturer
- Manufacturer
- Blackfish Industries(Shanghai) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050868
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED 27275cab-0f06-4e98-b1e1-e21b68baa85d 61 fields · synced Jul 9, 2026