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EurobioPlex DNA QC Control of DNA extraction and amplification

EUDAMED

Class IVD General (EU MDR)

Ref EBX-002

by Eurobio Scientific

Identity

Trade Name
EurobioPlex DNA QC Control of DNA extraction and amplification EUDAMED
Device Name
EurobioPlex DNA QC Control of DNA extraction and amplification EUDAMED
Model / Reference
EBX-002 EUDAMED

Identifiers

Primary DI / UDI-DI
D-EBX-002Q4 EUDAMED
Basic UDI-DI
B-EBX-002Q4 EUDAMED
EMDN Code
W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER EUDAMED

Classification

Device Class
Class IVD General 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

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Multiple bacteria species culture isolate identification control IVD, kit

EurobioPlex DNA QC Control of DNA extraction and amplification by Eurobio Scientific — Class IVD General — IVDD — listed in EUDAMED

Similar devices

Also classified as Multiple bacteria species culture isolate identification control IVD, kit.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Eurobio Scientific
EUDAMED SRN
FR-MF-000011745

Sources (1)

  • EUDAMED 7646f76b-7388-49e6-a044-d7c08997766d 61 fields · synced Jun 18, 2026