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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

E-IX-480 — IVDD — General IVDD by LaCAR MDx Technologies

MD Atlas
LaCAR MDx Technologies

EUDAMED last updated this device on Apr 20, 2026

E-IX-480

B-05430002471914

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: 05430002471914
Reference / catalog number: E-IX-480

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View device family (Basic UDI)

Manufacturer information

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

Related devices

I-MD-288B-05430002471983On the market I-ME-288B-05430002471990On the market J-LS-480PartBB-05430002471648On the market J-LS-96PartAB-05430003908013On the market E-KH-1920B-05430002471952On 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.

Critical warnings

No critical warnings reported for this device.

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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: 05430002471914
Basic UDI-DI: B-05430002471914
Reference / catalog number: E-IX-480
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 Neonatal G-6-PD Screening Assay is an enzymatic assay for the quantitative determination of G-6-PD activity. The kit has been designed for neonates’ samples1 using blood spot dried on 903® or 226 filter paper2. This device is used by health professionals in a laboratory environment for G-6-PD deficiency screening. The kit should not be used for confirmatory testing. The kit can be used manually.
Additional information URL: https://www.lacar-mdx.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification

UDI-DI DataMatrix

Encoded

(01)05430002471914

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W01010199ENZYMES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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