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evidence INVESTIGATOR

EUDAMED

Class A (EU MDR)

Ref EV3602

by Randox Laboratories Limited

Identity

Trade Name
evidence INVESTIGATOR EUDAMED
Device Name
evidence INVESTIGATOR EUDAMED
Model / Reference
EV3602 EUDAMED

Identifiers

Primary DI / UDI-DI
05055273209952 EUDAMED
Basic UDI-DI
50552732AEVINVE026MR EUDAMED
Direct Marketing DI
05055273209952 EUDAMED
EMDN Code
W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Northern Ireland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

evidence INVESTIGATOR by Randox Laboratories Limited — 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
XI-MF-000028410

Sources (1)

  • EUDAMED 4105ed15-6602-4449-b09e-d39cb76afc03 61 fields · synced Jul 30, 2026