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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 Bordetella pertussis… — IVDD — General IVDD

MD Atlas
Eurobio Scientific

EUDAMED last updated this device on Apr 9, 2026

EurobioPlex Bordetella pertussis and parapertussis

B-EBX-001-48B9

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-001-48B9
Reference / catalog number: EBX-001-48

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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 Bordetella pertussis and parapertussis
UDI-DI code: D-EBX-001-48B9
Basic UDI-DI: B-EBX-001-48B9
Reference / catalog number: EBX-001-48
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 Bordetella pertussis/parapertussis test is a real-time polymerase chain reaction (PCR) amplification test designed for the qualitative detection of the presence or absence of Bordetella pertussis and Bordetella parapertussis in a DNA nucleic acid extract. The test is indicated for the presumptive diagnosis of infection with Bordetella pertussis or Bordetella parapertussis in humans. The DNA extract is the starting material for the Eurobioplex Bordetella pertussis/parapertussis kit. The EurobioPlex Bordetella pertussis/parapertussis has been validated for the following sample type: nasopharyngeal aspirate. The EBX-001-48 device allows for 48 reactions.
Additional information URL: https://www.eurobio-scientific.com/fr/produit/eurobioplex-bordetella-pertussis-and-bordetella-parapertussis/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105011607BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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