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Toxo IgG Avidity Control
EUDAMEDClass C (EU MDR)
Ref 105-029872-00Model 105-029863-00、105-029867-00、105-029872-00、105-029873-00、105-029874-00、105-029875-00、105-029876-00、105-029877-00、105-029878-00、105-029879-00
Identity
- Trade Name
- Toxo IgG Avidity Control EUDAMED
- Device Name
- Toxoplasma gondii IgG Avidity（CLIA）、Toxo IgG Avidity Control EUDAMED
- Model / Reference
- 105-029863-00、105-029867-00、105-029872-00、105-029873-00、105-029874-00、105-029875-00、105-029876-00、105-029877-00、105-029878-00、105-029879-00 EUDAMED105-029872-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06903053060066 EUDAMED
- Basic UDI-DI
- 69449040AB74000255L EUDAMED
- Direct Marketing DI
- 06903053060066 EUDAMED
- EMDN Code
- W0105080805 PARASITOLOGY CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class C 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
New Device
No
EUDAMED
Toxo IgG Avidity Control by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69449040AB74000255L | Class C | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ac13aa97-1a87-4f94-b3e1-463dd49adad7 61 fields · synced Jun 19, 2026