← Back to catalogue

HCG STAT (eCLIA)

EUDAMED

Class IVD General (EU MDR)

Ref 0320509304Model 2×100TRef 0320509301Model 50TRef 0320509303Model 100TRef 0320509302Model 2×50T

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name
HCG STAT (eCLIA) EUDAMED
Device Name
HCG STAT (eCLIA) EUDAMED
Model / Reference
2×100T EUDAMED
0320509304 EUDAMED
50T EUDAMED
0320509301 EUDAMED
100T EUDAMED
0320509303 EUDAMED
2×50T EUDAMED
0320509302 EUDAMED

Identifiers

Primary DI / UDI-DI
06975984064208 EUDAMED
06975984064178 EUDAMED
06975984064192 EUDAMED
06975984064185 EUDAMED
Basic UDI-DI
B-06975984064208 EUDAMED
B-06975984064178 EUDAMED
B-06975984064192 EUDAMED
B-06975984064185 EUDAMED
EMDN Code
W0102050206 B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) 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

HCG STAT (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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (4)

  • EUDAMED cbd634fb-007a-4431-80cb-524b994536bb 61 fields · synced Aug 2, 2026
  • EUDAMED 0172ab70-42fc-4349-8226-2857491e2ee3 61 fields · synced May 17, 2026
  • EUDAMED 325b7c28-c690-4701-9401-15b5e17b5290 61 fields · synced May 18, 2026
  • EUDAMED bc4a4808-62eb-403e-a5df-caa591db4bbc 61 fields · synced May 18, 2026