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Multifunctional blood analyzer
EUDAMEDClass A (EU MDR)
Ref A060026Model HEA-5000S
Identity
- Trade Name
- Multifunctional blood analyzer EUDAMED
- Device Name
- Multifunctional blood analyzer EUDAMED
- Model / Reference
- HEA-5000S EUDAMEDA060026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674896945 EUDAMED
- Basic UDI-DI
- 69746748900191A2 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) 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
Multifunctional blood 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 | 69746748900191A2 | 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 (1)
- EUDAMED e0e3f91f-d0f8-4bdd-a041-974740f23d8f 61 fields · synced Jun 18, 2026