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ST2 (eCLIA)

EUDAMED

Class IVD General (EU MDR)

Ref 0320514801Model 50TRef 0320514804Model 2×100TRef 0320514803Model 100TRef 0320514802Model 2×50T

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name
ST2 (eCLIA) EUDAMED
Device Name
ST2 (eCLIA) EUDAMED
Model / Reference
50T EUDAMED
0320514801 EUDAMED
2×100T EUDAMED
0320514804 EUDAMED
100T EUDAMED
0320514803 EUDAMED
2×50T EUDAMED
0320514802 EUDAMED

Identifiers

Primary DI / UDI-DI
06978139078426 EUDAMED
06978139078457 EUDAMED
06978139078440 EUDAMED
06978139078433 EUDAMED
Basic UDI-DI
B-06978139078426 EUDAMED
B-06978139078457 EUDAMED
B-06978139078440 EUDAMED
B-06978139078433 EUDAMED
EMDN Code
W01021314 ST2 EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Netherlands 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

ST2 (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Shenzhen Lifotronic Technology Co., Ltd.
EUDAMED SRN
CN-MF-000005654
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (4)

  • EUDAMED bba71483-b887-42de-b2fd-304aede08ba7 61 fields · synced Aug 3, 2026
  • EUDAMED c1caaa0d-50ad-408f-bbc3-7b273f8a846d 61 fields · synced May 17, 2026
  • EUDAMED 66cedb6e-980a-4710-bca4-7f6fcffbfb52 61 fields · synced May 17, 2026
  • EUDAMED 0eb4f122-1b07-4f7e-af96-c2e352421970 61 fields · synced May 18, 2026