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Automatic fluorescence microscopic image scanning analyzer
EUDAMEDClass A (EU MDR)
Ref GKPD079Model GK-IMG1000 / GK-IMG3000 / GK-IMG5000
Identity
- Trade Name
- Automatic fluorescence microscopic image scanning analyzer EUDAMED
- Device Name
- Automatic fluorescence microscopic images scanning analyzer EUDAMED
- Model / Reference
- GK-IMG1000 / GK-IMG3000 / GK-IMG5000 EUDAMEDGKPD079 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698400433 EUDAMED
- Basic UDI-DI
- 697769840GKPD07976 EUDAMED
- Direct Marketing DI
- 06977698400433 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
Automatic fluorescence microscopic image scanning analyzer by Dezhou Guoke Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 697769840GKPD07976 | 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 3f11ab53-e5c3-46d9-a2b6-de7b33403f15 61 fields · synced Oct 6, 2026