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Automatic POCT Hematology Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref HE10011Model PB30
Identity
- Trade Name
- Automatic POCT Hematology Analyzer EUDAMED
- Device Name
- Automatic POCT Hematology Analyzer EUDAMED
- Model / Reference
- PB30 EUDAMEDHE10011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975838800907 EUDAMED
- Basic UDI-DI
- B-06975838800907 EUDAMED697583880MH001NB EUDAMED
- EMDN Code
- W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMEDW0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Czechia EUDAMEDItaly 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
Automatic POCT Hematology Analyzer by Zhejiang Pushkang Biotechnology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06975838800907 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975838800907 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Pushkang Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000042656
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 3ac47b26-735e-4c78-865c-dd1c233eeb06 61 fields · synced Jul 14, 2026
- EUDAMED 483db285-939e-479b-a6b9-fca3982d736a 61 fields · synced Jul 14, 2026