Follicle-stimulating Hormone (Electrochemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 697026Model 2×100TModel 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: 2×100T EUDAMED
697026 EUDAMED
50T 2×50T 100T 2×100T EUDAMED

Identifiers

Primary DI / UDI-DI: 06970341681173 EUDAMED
Basic UDI-DI: B-06970341681173 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

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	B-06970341681173	Class IVD General	Active
EUDAMED	European Union	CE/IVDD	B-06970341681173	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 cce91423-e03b-4f31-ad01-10e2308eeea7 61 fields · synced Jul 14, 2026
EUDAMED 81d8a9ff-1ac1-445f-b6de-8b0734653b05 61 fields · synced May 19, 2026