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Fully Auto 5-Part Hematology Analyzer
EUDAMEDClass B (EU MDR)
Ref GKPD082Model GK-CBC500
Identity
- Trade Name
- Fully Auto 5-Part Hematology Analyzer EUDAMED
- Device Name
- Fully Auto 5-Part Hematology Analyzer EUDAMED
- Model / Reference
- GK-CBC500 EUDAMEDGKPD082 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698403885 EUDAMED
- Basic UDI-DI
- 697769840GKPD0826T EUDAMED
- Direct Marketing DI
- 06977698403885 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class B 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
Fully Auto 5-Part Hematology Analyzer by Dezhou Guoke Medical Technology Co., Ltd. — Class B — 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 | 697769840GKPD0826T | Class B | Active |
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Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED e8882d9e-ae75-4cbc-b3a9-30c6d1b1971b 61 fields · synced Jun 18, 2026