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Fully Auto 3-PartHematology Analyzer
EUDAMEDClass A (EU MDR)
Ref GKPD081Model GK-CBC300
Identity
- Trade Name
- Fully Auto 3-PartHematology Analyzer EUDAMED
- Device Name
- Fully Auto 3-Part Hematology Analyzer EUDAMED
- Model / Reference
- GK-CBC300 EUDAMEDGKPD081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698403007 EUDAMED
- Basic UDI-DI
- 697769840GKPD0816R EUDAMED
- Direct Marketing DI
- 06977698403007 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Fully Auto 3-PartHematology Analyzer by Dezhou Guoke Medical Technology 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 | 697769840GKPD0816R | Class A | 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 cfecfe24-7707-4201-9b69-5a60ee2ae20a 61 fields · synced Oct 6, 2026