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Thyroid Stimulating Hormone (TSH) Assay Kits (Lateral Flow Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 745013Model 25 Tests/Kit
Identity
- Trade Name
- Thyroid Stimulating Hormone (TSH) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Device Name
- Thyroid Stimulating Hormone (TSH) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED745013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139075999 EUDAMED
- Basic UDI-DI
- B-06978139075999 EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 (TSH) Assay Kits (Lateral Flow Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in…
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-06978139075999 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2f68c6f0-aa08-4384-b878-3e886331eaf6 61 fields · synced Jul 19, 2026