Thyroid-stimulating Hormone (TSH) Test Kit (Immunofluorescence)
by Nanjing Norman Biological Technology Co., Ltd.
Ref 22402810500010Model 25 Tests /Box
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06921893001179 06921893001179 | Date2 Sep 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- 25 Tests /Box, 22402810500010
- Primary DI / UDI-DI
- 06921893001179
- Basic UDI-DI
- B-06921893001179
- EMDN Code
- W01020410 Thyroid stimulating hormone
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000024233
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No