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Dry Fluorescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref GKPD016Model GKYG-500、GKYG-600、GKYG-800、GKYG-1000、GKYG-2000、GKYG-3000
Identity
- Trade Name
- Dry Fluorescence Immunoassay Analyzer EUDAMED
- Device Name
- Dry Fluorescence Immunoassay Analyzer EUDAMED
- Model / Reference
- GKYG-500、GKYG-600、GKYG-800、GKYG-1000、GKYG-2000、GKYG-3000 EUDAMEDGKPD016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698401003 EUDAMED
- Basic UDI-DI
- 697769840GKPD0166E EUDAMED
- Direct Marketing DI
- 06977698401003 EUDAMED
- EMDN Code
- W0201010185 CHEMISTRY ANALYSERS - CONSUMABLES 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
Dry Fluorescence Immunoassay 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 | 697769840GKPD0166E | 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 16bb7a53-624b-4fdd-81fc-37564455e7d2 61 fields · synced Jul 16, 2026