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Thyroid Stimulating Hormone Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3008743Model 1×100 Tests/kitRef 3013752Model 1×50 Tests/kitRef 3013730Model 2×50 Tests/kit
Identity
- Trade Name
- Thyroid Stimulating Hormone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Thyroid Stimulating Hormone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×100 Tests/kit EUDAMED3008743 EUDAMED1×50 Tests/kit EUDAMED3013752 EUDAMED2×50 Tests/kit EUDAMED3013730 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794511829 EUDAMED06925794520197 EUDAMED06942202223914 EUDAMED
- Basic UDI-DI
- B-06925794511829 EUDAMEDB-06925794520197 EUDAMEDB-06942202223914 EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE 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
Thyroid Stimulating Hormone 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-06925794511829 | 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 (3)
- EUDAMED 5b2d74a8-398a-4492-9483-089d7abfbbe6 61 fields · synced Sep 17, 2026
- EUDAMED ddd7c166-2559-436c-904b-1291c1ff6ba4 61 fields · synced May 17, 2026
- EUDAMED 6c36be29-9157-4e61-9680-adee22c40398 61 fields · synced May 18, 2026