Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

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

MD Atlas
LaCAR MDx Technologies

EUDAMED last updated this device on Apr 10, 2026

LC-HFE-LP-24

B-05430002471068

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: 05430002471068
Reference / catalog number: LC-HFE-LP-24

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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: 05430002471068
Basic UDI-DI: B-05430002471068
Reference / catalog number: LC-HFE-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 Hemochromatosis KIT (rs1800562/rs1799945) is an in vitro diagnostic test intended for the qualitative detection of the C282Y and H63D mutations by Loop mediated isothermal amplification (LAMP) on EDTA anticoagulated whole blood and extracted DNA samples. This test is intended to as an aid to the diagnosis of hemochromatosis mutations C282Y and H63D. 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)

W0106010105HAEMOCHROMATOSIS

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

J-LS-96PartAB-05430003908013On the market I-ME-288B-05430002471990On the market J-LS-480PartBB-05430002471648On the market J-LS-480PartAB-05430002471631On the market I-MD-288B-05430002471983On 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.