Total T3 Calibrators
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-004279-00Model 105-004210-00、105-004237-00、105-004279-00 EMDN W0102152202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB74000035A | Date13 Jul 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Total Triiodothyronine (CLIA), Total T3 Calibrators
- Model / Reference
- 105-004210-00、105-004237-00、105-004279-00, 105-004279-00
- Primary DI / UDI-DI
- 06944904048208
- Basic UDI-DI
- 69449040AB74000035A
- EMDN Code
- W0102152202 Hormone standards and calibrators
- 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 (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 7dc1986f-7a9e-4e42-b583-292d88b5ed90