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Thyroid stimulating hormone (Electrochemiluminescence immunoassay)
EUDAMEDClass B (EU MDR)
Ref 690062Model 100 T
Identity
- Trade Name
- Thyroid stimulating hormone (Electrochemiluminescence immunoassay) EUDAMED
- Device Name
- Thyroid stimulating hormone (Electrochemiluminescence immunoassay) EUDAMED
- Model / Reference
- 690062 EUDAMED100 T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341689445 EUDAMED
- Basic UDI-DI
- 69703416803205001HV EUDAMEDB-06970341689445 EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General 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 B — IVDD, IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69703416803205001HV | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 69703416803205001HV | Class B | 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 d2d870fb-f9f7-4834-9f07-629f5f755f84 61 fields · synced Jul 11, 2026
- EUDAMED 221b8a89-68c5-4e84-9e7d-3309ba67dc4e 61 fields · synced May 19, 2026