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Aspergillus IgM Antibody Detection K-Set(CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref AMCLIA-01
Identity
- Trade Name
- Aspergillus IgM Antibody Detection K-Set(CLIA) EUDAMED
- Device Name
- Aspergillus IgM Antibody Detection K-Set(CLIA) EUDAMEDAspergillus IgM Antibody Detection Kit (CLIA) EUDAMED
- Model / Reference
- AMCLIA-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514080635 EUDAMED
- Basic UDI-DI
- B-06970514080635 EUDAMED
- EMDN Code
- W0105060301 ASPERGILLUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Aspergillus IgM Antibody Detection K-Set(CLIA) by Genobio Pharmaceutical Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06970514080635 | 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 (2)
- EUDAMED 0fb7785f-b893-4c0f-ab78-555d177f5185 61 fields · synced Jul 12, 2026
- EUDAMED e01a677e-52a2-487f-a16b-bacbf77366d5 61 fields · synced Jul 12, 2026