Reverse Triiodothyronine (CLIA)
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-010692-00Model 105-010692-00、105-010719-00、105-010213-00、105-010220-00、105-010240-00、 105-010250-00105-010230-00 EMDN W01020404
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040004S-rT3*******8N | Date16 Aug 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Reverse Triiodothyronine (CLIA)、rT3 Calibrators、rT3 Control
- Model / Reference
- 105-010692-00、105-010719-00、105-010213-00、105-010220-00、105-010240-00、 105-010250-00105-010230-00, 105-010692-00
- Primary DI / UDI-DI
- 06936415900441
- Basic UDI-DI
- 69449040004S-rT3*******8N
- EMDN Code
- W01020404 Reverse triiodothyronine
- Device Class
- Class B
- 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
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 10304527-adc2-4749-adcb-dce401bbe99f