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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

LJ031 — IVDR Class A IVDR by DIAGNOTIS SAS

MD Atlas
DIAGNOTIS SAS

EUDAMED last updated this device on Feb 13, 2024

LJ031

3770032939LJ031UD

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: DIAGNOTIS SAS
UDI-DI code: 03770032939063
Reference / catalog number: LJ031

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Manufacturer information

Organization name: DIAGNOTIS SAS
SRN: FR-MF-000035861
Manufacturer status: Active

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: not provided
UDI-DI code: 03770032939063
Basic UDI-DI: 3770032939LJ031UD
Reference / catalog number: LJ031
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: TK LJRed® est un milieu Löwenstein-Jensen (LJ) amélioré, qui permet la détermination rapide de la croissance de mycobactéries. Les résultats de la culture soutiennent le diagnostic de la tuberculose. Il est destiné au diagnostic in vitro.
Additional information URL: https://www.diagnotis.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104010604MANUAL MYCOBACTERIA MEDIA (TUBES & BOTTLES)

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

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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.