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Candida Mannan IgG Antibody Detection K-Set(CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref CGCLIA-01
Identity
- Device Name
- Candida Mannan IgG Antibody Detection K-Set(CLIA) EUDAMED
- Model / Reference
- CGCLIA-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514080659 EUDAMED
- Basic UDI-DI
- B-06970514080659 EUDAMED
- EMDN Code
- W0105060302 CANDIDA ALBICANS 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
Candida Mannan IgG Antibody Detection K-Set(CLIA) by Genobio Pharmaceutical Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06970514080659 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- EUDAMED SRN
- CN-MF-000027997
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED eb43702f-96b1-4070-99e9-0c8c79089a22 61 fields · synced Jun 18, 2026