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Follicle-stimulating Hormone (Electrochemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 697019Model 50TModel 50T 2×50T 100T 2×100T

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name
Follicle-stimulating Hormone (Electrochemiluminescence Immunoassay) EUDAMED
Device Name
Follicle-stimulating Hormone (Electrochemiluminescence Immunoassay) EUDAMED
Model / Reference
50T EUDAMED
697019 EUDAMED
50T 2×50T 100T 2×100T EUDAMED

Identifiers

Primary DI / UDI-DI
06970341685898 EUDAMED
Basic UDI-DI
B-06970341685898 EUDAMED
69703416803205055JL EUDAMED
EMDN Code
W0102050104 FOLLICLE STIMULATING HORMONE EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class B 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

Follicle-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

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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 4b8c9774-197b-4fc2-83f3-17f4f5fa5052 61 fields · synced Jul 18, 2026
  • EUDAMED 06b22d4b-5b8b-441d-aef2-1adfeb6cd217 61 fields · synced May 19, 2026