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Malaria IgG/IgM Antibody Assay Kit(Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref 1 Test/Kit
Identity
- Device Name
- Malaria IgG/IgM Antibody Assay Kit(Colloidal Gold) EUDAMED
- Model / Reference
- 1 Test/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975166201223 EUDAMED
- Basic UDI-DI
- B-06975166201223 EUDAMED
- EMDN Code
- W0105090401 PLASMODIUM (MALARIA) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Malaria IgG/IgM Antibody Assay Kit(Colloidal Gold) by Avioq Bio-tech 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-06975166201223 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Avioq Bio-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000048146
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 072aa11e-54fc-4edb-8458-7def1c0c6a67 61 fields · synced Jul 23, 2026