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Fungus(1-3)-β-D-Glucan Test (Chromogenic Method)
EUDAMEDClass IVD General (EU MDR)
Ref GKT-25M
Identity
- Device Name
- Fungus(1-3)-β-D-Glucan Test (Chromogenic Method) EUDAMED
- Model / Reference
- GKT-25M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970489560286 EUDAMED
- Basic UDI-DI
- B-06970489560286 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Fungus(1-3)-β-D-Glucan Test (Chromogenic Method) by Beijing Gold Mountainriver Tech Development Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06970489560286 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000028661
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 2a5e0366-73c9-4a6f-b022-0e03da72bde4 61 fields · synced Jun 19, 2026