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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

2111 — IVDD — General IVDD by LaCAR MDx Technologies

MD Atlas
LaCAR MDx Technologies

EUDAMED last updated this device on Apr 22, 2026

2111

B-05430003908716

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: 05430003908716
Reference / catalog number: 2111

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Manufacturer information

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

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: 05430003908716
Basic UDI-DI: B-05430003908716
Reference / catalog number: 2111
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 SEEKER® LSD Reagent Kit - IDUA|GAA|GBA|GLA is intended for quantitative measurement of the activity of α-L-iduronidase, α-D-glucosidase, β-glucocerebrosidase and α-D-galactosidase A from newborn dried blood spot specimens, using the SEEKER Instrument as an aid in screening newborns for Mucopolysaccharidosis Type I, Pompe, Gaucher and Fabry diseases. Reduced activity of these enzymes may be indicative of these lysosomal storage diseases. The enzymes measured using the SEEKER LSD Reagent Kit- IDUA|GAA|GBA|GLA and their associated lysosomal storage diseases are listed below.
Additional information URL: https://www.lacar-mdx.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01010199ENZYMES - 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

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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.