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PlasDispo

EUDAMED

Class A (EU MDR)

Ref SV810-113

by DiaTrust Medical Co., Ltd

Identity

Trade Name
PlasDispo EUDAMED
Device Name
Sterile Specimen Container EUDAMED
Model / Reference
SV810-113 EUDAMED

Identifiers

Primary DI / UDI-DI
06974570465955 EUDAMED
Basic UDI-DI
6974570461117BX EUDAMED
Direct Marketing DI
06974570465955 EUDAMED
EMDN Code
W05010203 URINE COLLECTION, CONTAINERS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Northern Ireland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

PlasDispo by DiaTrust Medical Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000009279
Authorised Representative
Wellkang Ltd XI-AR-000001836

Sources (1)

  • EUDAMED c2a9e296-61d8-489d-9c7d-1f4a567af743 61 fields · synced Jul 9, 2026