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Estradiol (Electrochemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref 697034Model 50T 2×50T 100T 2×100TModel 2×100T
Identity
- Trade Name
- Estradiol (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Estradiol (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 50T 2×50T 100T 2×100T EUDAMED697034 EUDAMED2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341681203 EUDAMED
- Basic UDI-DI
- 69703416803205058JS EUDAMEDB-06970341681203 EUDAMED
- EMDN Code
- W0102050103 ESTRADIOL EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass 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
New Device
No
EUDAMED
Estradiol (Electrochemiluminescence Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class B — IVDR, IVDD — listed in EUDAMED
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 | 69703416803205058JS | Class B | Active |
| EUDAMED | European Union | CE/IVDD | 69703416803205058JS | 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 18b67663-a56c-45f6-944e-b3d8593e1af2 61 fields · synced Jun 19, 2026
- EUDAMED 293772dc-7993-49f9-84c1-647e23df1b62 61 fields · synced May 17, 2026