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Toxoplasma gondii (Toxo) IgG/IgM Rapid Test
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref GCTOX(IgG/IgM)-302a
Identity
- Trade Name
- Toxoplasma gondii (Toxo) IgG/IgM Rapid Test EUDAMED
- Device Name
- Toxoplasma gondii (Toxo) IgG/IgM Rapid Test EUDAMED
- Model / Reference
- GCTOX(IgG/IgM)-302a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCTOX(IgG/IgM)-302a4G EUDAMED
- Basic UDI-DI
- B-GCTOX(IgG/IgM)-302a4G EUDAMED
- EMDN Code
- W0105050101 TOXOPLASMA ANTIBODY (TOTAL) 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
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Toxoplasma gondii (Toxo) IgG/IgM Rapid Test by Zhejiang Orient Gene Biotech 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-GCTOX(IgG/IgM)-302a4G | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 4d362d16-bf54-4a28-8065-ceb39bde78a3 61 fields · synced Jun 19, 2026