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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

Genexpath — IVDD — General IVDD by Genexpath

MD Atlas
Genexpath

EUDAMED last updated this device on Oct 9, 2025

Genexpath

B-03770026953006

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Genexpath
UDI-DI code: 03770026953006
Reference / catalog number: GEP-LS08

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Manufacturer information

Organization name: Genexpath
SRN: FR-MF-000029325
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 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: Genexpath
UDI-DI code: 03770026953006
Basic UDI-DI: B-03770026953006
Reference / catalog number: GEP-LS08
Issuing entity: GS1

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 LymphoSign test provides an accurate measurement of the expression signature of more than 130 genes of interest in non-Hodgkin lymphomas.
Additional information URL: https://www.clinisciences.com/en/other-products-186/lymphosign-kit-1469000001.html
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

GenexpathB-03770026953037On the market GenexpathB-03770026953020On the market GenexpathB-03770026953044On the market GenexpathB-03770026953075On the market GenexpathB-03770026953013On the market

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.