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Livsane Tests D'ovulation

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref 10922Model Midstream

by Core Technology Co., Ltd.

Identity

Trade Name
LIVSANE TESTS D'OVULATION EUDAMED
Device Name
LH Ovulation Tests EUDAMED
Model / Reference
Midstream EUDAMED
10922 EUDAMED

Identifiers

Primary DI / UDI-DI
06942468134368 EUDAMED
Basic UDI-DI
B-06942468134368 EUDAMED
EMDN Code
W0102160304 LH - RT & POC EUDAMED

Classification

Device Class
Class IVD devices for self-testing EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Livsane Tests D'ovulation by Core Technology Co., Ltd. — Class IVD devices for self-testing — 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

EUDAMED SRN
CN-MF-000023522
Authorised Representative
Wellkang Ltd XI-AR-000001836

Sources (1)

  • EUDAMED f39cf1f0-bfca-45a3-bccf-f23514d4bf43 61 fields · synced Jul 11, 2026