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Organization name
UDI-DI code
Reference / catalog number

EurobioPlex DNA QC Control of DNA… — IVDD — General IVDD

MD Atlas
Eurobio Scientific

EUDAMED last updated this device on Apr 24, 2026

EurobioPlex DNA QC Control of DNA extraction and amplification

B-EBX-002Q4

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Eurobio Scientific
UDI-DI code: D-EBX-002Q4
Reference / catalog number: EBX-002

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Manufacturer information

Organization name: Eurobio Scientific
SRN: FR-MF-000011745
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: EurobioPlex DNA QC Control of DNA extraction and amplification
UDI-DI code: D-EBX-002Q4
Basic UDI-DI: B-EBX-002Q4
Reference / catalog number: EBX-002
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The EurobioPlex DNA QC Control of DNA extraction and amplification Kit is used to control variations that may occur during the DNA preparation step from biological samples and real-time PCR amplification. The DNA internal control ensures that a negative result is not due to a DNA preparation problem or due to the presence of PCR inhibitors in high amounts. The kit is not intended to be used for other real-time PCR applications.
Additional information URL: https://www.eurobio-scientific.com/fr/produit/eurobioplex-dna-qc/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01040699CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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