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Mercurochrome TESTS DE GROSSESSE

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref 050614Model MidstreamRef 050615Ref 050619

by Core Technology Co., Ltd.

Identity

Trade Name
Mercurochrome TESTS DE GROSSESSE EUDAMED
Mercurochrome TEST DE GROSSESSE EUDAMED
Mercurochrome TEST DE GROSSESSE PRÉCOCE EUDAMED
Device Name
HCG Pregnancy Tests EUDAMED
Model / Reference
Midstream EUDAMED
050614 EUDAMED
050615 EUDAMED
050619 EUDAMED

Identifiers

Primary DI / UDI-DI
06942468134726 EUDAMED
06942468134719 EUDAMED
06942468134733 EUDAMED
Basic UDI-DI
B-06942468134726 EUDAMED
B-06942468134719 EUDAMED
B-06942468134733 EUDAMED
EMDN Code
W0102160302 HCG - 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

Mercurochrome TESTS DE GROSSESSE 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 (3)

  • EUDAMED a65fed24-6be1-4b7f-acb2-b7a3a07ffd07 61 fields · synced Jul 22, 2026
  • EUDAMED 403b087d-18c2-409b-90b4-03be509715f0 61 fields · synced May 17, 2026
  • EUDAMED 5783af0f-62fe-405c-824a-b3cca44ae4a3 61 fields · synced May 18, 2026