Identity
- Device Name
- BJB Rapid Gene Detection System EUDAMED
- Model / Reference
- A-1-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102680013 EUDAMED
- Basic UDI-DI
- 697510268A001B2 EUDAMED
- Direct Marketing DI
- 06975102680013 EUDAMED
- EMDN Code
- W02050115 DNA SYNTHESIZERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
BJB Rapid Gene Detection System by Jiangsu Bojia Biomedical Technology Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697510268A001B2 | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bojia Biomedical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000023653
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 40924a17-2e0d-45ab-99b7-a4d07253b5c2 61 fields · synced Jun 18, 2026