ToRCH IgG/IgM Negative Control
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-024827-00Model 105-024824-00、105-024825-00、105-024826-00、105-024827-00 EMDN W0105080807
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB74000185P | Date9 Oct 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 105-024824-00、105-024825-00、105-024826-00、105-024827-00, 105-024827-00
- Primary DI / UDI-DI
- 06903053020992
- Basic UDI-DI
- 69449040AB74000185P
- EMDN Code
- W0105080807 Multiconstituent controls - inf.imm.
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 6f1f302d-67b8-455c-9897-3fee2aca81da