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Fully automatic pathological slide scanning analyzer
EUDAMEDClass A (EU MDR)
Ref GKPD083Model GK-APSSA8300、GK-APSSA8500、GK-APSSA8600
Identity
- Trade Name
- Fully automatic pathological slide scanning analyzer EUDAMED
- Device Name
- Fully automatic pathological slide scanning analyzer EUDAMED
- Model / Reference
- GK-APSSA8300、GK-APSSA8500、GK-APSSA8600 EUDAMEDGKPD083 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698403946 EUDAMED
- Basic UDI-DI
- 697769840GKPD0836V EUDAMED
- Direct Marketing DI
- 06977698403946 EUDAMED
- EMDN Code
- W02079099 VARIOUS GENERAL PURPOSE 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
Fully automatic pathological slide 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 | 697769840GKPD0836V | 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 848ff8e4-7006-4bc2-b57c-1eaa179a2ac4 61 fields · synced Aug 1, 2026