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Thyroid stimulating hormone (Electrochemiluminescence immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 690060Model 50 T
Identity
- Trade Name
- Thyroid stimulating hormone (Electrochemiluminescence immunoassay) EUDAMED
- Device Name
- Thyroid stimulating hormone (Electrochemiluminescence immunoassay) EUDAMED
- Model / Reference
- 50 T EUDAMED690060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341689438 EUDAMED
- Basic UDI-DI
- B-06970341689438 EUDAMED69703416803205001HV EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
Thyroid stimulating hormone (Electrochemiluminescence immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06970341689438 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970341689438 | 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 (2)
- EUDAMED 2999defb-7176-48ff-997b-7af6ccb2e170 61 fields · synced Jul 15, 2026
- EUDAMED 6636689d-135a-4381-a97b-dbe462830ffd 61 fields · synced May 19, 2026