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TOXO Toxoplasma Antibody IgM Rapid Test Kit (Colloidal Gold)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref /
Identity
- Trade Name
- TOXO Toxoplasma Antibody IgM Rapid Test Kit (Colloidal Gold) EUDAMED
- Device Name
- TOXO Toxoplasma Antibody IgM Rapid Test Kit (Colloidal Gold) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935091671775 EUDAMED
- Basic UDI-DI
- B-06935091671775 EUDAMED
- EMDN Code
- W0105090499 PARASITES - RT & POC - OTHER 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
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
TOXO Toxoplasma Antibody IgM Rapid Test Kit (Colloidal Gold) by Qingdao Hightop 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-06935091671775 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Qingdao Hightop Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000016890
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED f4ed1f01-dd5c-46f0-b65b-19672fa24e1e 61 fields · synced Jul 11, 2026