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Logilet STl Panel

EUDAMED

Class IVD General (EU MDR)

Ref VD4021

by Nanjing Vazyme Medical Technology Co., Ltd.

Identity

Trade Name
Logilet STl Panel EUDAMED
Device Name
Logilet STl Panel EUDAMED
Model / Reference
VD4021 EUDAMED

Identifiers

Primary DI / UDI-DI
06973315739375 EUDAMED
Basic UDI-DI
B-06973315739375 EUDAMED
EMDN Code
W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

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

Logilet STl Panel by Nanjing Vazyme Medical 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

EUDAMED SRN
CN-MF-000031032
Authorised Representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Sources (1)

  • EUDAMED 5011df2d-d8f6-4e5c-ba8c-5bd1bbb0c787 61 fields · synced Jun 18, 2026