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Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013871Model 2×50 Tests/kitRef 3013826Model 1×50 Tests/kit
Identity
- Trade Name
- Thyroglobulin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Thyroglobulin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50 Tests/kit EUDAMED3013871 EUDAMED1×50 Tests/kit EUDAMED3013826 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202223891 EUDAMED06925794520173 EUDAMED
- Basic UDI-DI
- B-06942202223891 EUDAMEDB-06925794520173 EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Thyroglobulin Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06942202223891 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d2a13502-be20-4936-afa1-518aa4783348 61 fields · synced Jul 10, 2026
- EUDAMED 77614947-60e1-4bdc-bb31-3c42430f24ae 61 fields · synced May 17, 2026