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Chemiluminescent Immunoassay Assay Kits for TOXO IgG
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref EIM4415116Model TOXO IgG Antibody Chemiluminescent Immunoassay Kit
Identity
- Device Name
- Chemiluminescent Immunoassay Assay Kits for TOXO IgG EUDAMED
- Model / Reference
- TOXO IgG Antibody Chemiluminescent Immunoassay Kit EUDAMEDEIM4415116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-EIM4415116GJ EUDAMED
- Basic UDI-DI
- B-EIM4415116GJ EUDAMED
- EMDN Code
- W0105050102 TOXOPLASMA ANTIBODY IGG EUDAMED
Classification
- Device Class
- Class IVD Annex II List B 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
Chemiluminescent Immunoassay Assay Kits for TOXO IgG by Maccura Biotechnology Co., Ltd. — Class IVD Annex II List B — 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-EIM4415116GJ | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 13684176-8fc3-4e2f-80a7-b3feff9aadc3 61 fields · synced Jun 18, 2026