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Fluorescence Biological Microscope
EUDAMEDClass A (EU MDR)
Ref GKPD004Model GK-23M、GK-33M、GK-500DM、GK-750DM
Identity
- Trade Name
- Fluorescence Biological Microscope EUDAMED
- Device Name
- Fluorescence Biological Microscope EUDAMED
- Model / Reference
- GK-23M、GK-33M、GK-500DM、GK-750DM EUDAMEDGKPD004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698400426 EUDAMED
- Basic UDI-DI
- 697769840GKPD00467 EUDAMED
- Direct Marketing DI
- 06977698400426 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER 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
Fluorescence Biological Microscope 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 | 697769840GKPD00467 | 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 1ad48299-6983-4067-9575-1038a8cfc93c 61 fields · synced Jun 18, 2026