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Multifunctional blood analyzer
EUDAMEDClass A (EU MDR)
Ref A060028Model HEA-5000SRef A060025Ref A060027
Identity
- Trade Name
- Multifunctional blood analyzer EUDAMED
- Device Name
- Multifunctional blood analyzer EUDAMED
- Model / Reference
- HEA-5000S EUDAMEDA060028 EUDAMEDA060025 EUDAMEDA060027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674896969 EUDAMED06974674896938 EUDAMED06974674896952 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 (3)
- EUDAMED 17272a9a-bcea-4dc6-9308-c165f6604a66 61 fields · synced Oct 6, 2026
- EUDAMED 2360e948-8cbc-4851-8698-47bf424523b5 61 fields · synced May 17, 2026
- EUDAMED db2d4859-213e-4fc9-a7ca-8159a2493b08 61 fields · synced May 18, 2026