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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

LC-FII-LP-24 — IVDD — General IVDD by LaCAR MDx Technologies

MD Atlas
LaCAR MDx Technologies

EUDAMED last updated this device on Apr 10, 2026

LC-FII-LP-24

B-05430002471006

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: LaCAR MDx Technologies
UDI-DI code: 05430002471006
Reference / catalog number: LC-FII-LP-24

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Manufacturer information

Organization name: LaCAR MDx Technologies
SRN: BE-MF-000001212
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW082
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05430002471006
Basic UDI-DI: B-05430002471006
Reference / catalog number: LC-FII-LP-24
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 “Lamp Human Prothrombin mutation KIT (rs1799963)”is an in vitro diagnostic test intended for the qualitative detection of Factor II G20210A polymorphism by Loop-mediated isothermal amplification (LAMP) on EDTA anticoagulated whole blood and extracted DNA samples. This test is intended to diagnose the Factor II G20210A polymorphism, in patients with suspected thrombophilia. This assay is dedicated to professional use in diagnostic laboratory. The device is not for self testing.
Additional information URL: https://www.lacar-mdx.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0106010114PROTHROMBIN MUTATION

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.