Troponin I (Electrochemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 691057Model 2×50TModel 50T, 2×50T ,100T, 2×100T

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name: Troponin I (Electrochemiluminescence Immunoassay) EUDAMED
hs-cTnI (eCLIA) EUDAMED
Device Name: Troponin I (Electrochemiluminescence Immunoassay) EUDAMED
hs-cTnI (eCLIA) EUDAMED
Model / Reference: 2×50T EUDAMED
691057 EUDAMED
50T, 2×50T ,100T, 2×100T EUDAMED

Identifiers

Primary DI / UDI-DI: 06975984063119 EUDAMED
Basic UDI-DI: B-06975984063119 EUDAMED
69703416803205036JG EUDAMED
EMDN Code: W01021306 TROPONIN I/T EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Class C 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

Troponin I (Electrochemiluminescence Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — 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	B-06975984063119	Class IVD General	Active
EUDAMED	European Union	CE/IVDR	B-06975984063119	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 104d08dd-14f3-4fc6-bc83-ed8621de93df 61 fields · synced Jul 17, 2026
EUDAMED 03e6eb75-6e0a-40e9-90f5-055917f3e7ef 61 fields · synced May 17, 2026