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Fungal D-Glucan Detection Fluorescent Staining Solution
EUDAMEDClass A (EU MDR)
Ref GKPD002Model 20 persons/box, 50 persons/box, 100 persons/box, 200 persons/box, 300 persons/box, 500 persons/box
Identity
- Trade Name
- Fungal D-Glucan Detection Fluorescent Staining Solution EUDAMED
- Device Name
- Fungal D-Glucan Detection Fluorescent Staining Solution EUDAMED
- Model / Reference
- 20 persons/box, 50 persons/box, 100 persons/box, 200 persons/box, 300 persons/box, 500 persons/box EUDAMEDGKPD002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698400136 EUDAMED
- Basic UDI-DI
- 697769840GKPD00263 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Fungal D-Glucan Detection Fluorescent Staining Solution by Dezhou Guoke Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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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 | 697769840GKPD00263 | 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 06984d8e-935d-4c19-a69c-926bd80f5b48 61 fields · synced Jun 18, 2026