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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

EurobioPlex Coxiella Burnetii — IVDD — General IVDD

MD Atlas
Eurobio Scientific

EUDAMED last updated this device on May 15, 2026

EurobioPlex Coxiella Burnetii

B-EBX-017-48CW

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-017-48CW
Reference / catalog number: EBX-017-48

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Manufacturer information

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

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 2 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Spain		Still on market

Device identification

Trade name: EurobioPlex Coxiella Burnetii
UDI-DI code: D-EBX-017-48CW
Basic UDI-DI: B-EBX-017-48CW
Reference / catalog number: EBX-017-48
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 Coxiella Burnetii device (EBX-017) is a test uses real time polymerase chain reaction (PCR) amplification and is designed for the qualitative detection of uburnetii from a DNA nucleic acids extract. This kit also contains a control of inhibition of PCR. This test is indicated to confirm a diagnosis of presumption of infection in patients or complete a proven or indeterminate diagnosis by standard techniques (diagnosis by serology, by culture, immunohistochemistry or gene amplification by PCR). Extracted DNA is the starting material for the EurobioPlex Coxiella burnetii. The EBX-017-48 reference is designed for performing 48 reactions.
Additional information URL: https://www.eurobio-scientific.com/fr/produit/eurobioplex-coxiella-burnetii/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105011603COXIELLA BURNETII (Q FEVER) - NA REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
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Software identification

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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.