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Semi-auto Chemistry Analyzer
EUDAMEDClass A (EU MDR)
Ref 29-06-0002Model BAS-10Ref 29-06-0003
Identity
- Device Name
- Semi-auto Chemistry Analyzer EUDAMED
- Model / Reference
- BAS-10 EUDAMED29-06-0002 EUDAMED29-06-0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674896105 EUDAMED06974674895016 EUDAMED
- Basic UDI-DI
- 697467489001659Z EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMEDW0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Semi-auto Chemistry Analyzer by Shenzhen Zijian Biotechnology 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 | 697467489001659Z | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Zijian Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000022829
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED e5b7cdcb-369b-4f07-8329-deb00625d78f 61 fields · synced Oct 6, 2026
- EUDAMED 5f21db9e-c5e9-4c77-b9ba-3d9bfaff3acc 61 fields · synced May 18, 2026