Antibodies to Thyroid Peroxidase Detection Kit (Chemiluminescence Immunoassay)
by Dirui Industrial Co., Ltd China EUDAMED
Ref 3013907Model 1×50 Tests/kit
EMDN W0102100301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-06925794520234 | Date28 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 1×50 Tests/kit, 3013907
- Primary DI / UDI-DI
- 06925794520234
- Basic UDI-DI
- B-06925794520234
- EMDN Code
- W0102100301 Thyroid peroxidase (incl. microsomal) antibodies
- Device Class
- Class IVD General
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000001891
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Dirui Industrial Co., Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 4c69f9ae-b49e-44f1-b4f6-a630c1faaca1