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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-KH-1920 — IVDD — General IVDD by Zentech s.a.

MD Atlas
Zentech s.a.

EUDAMED last updated this device on Apr 24, 2026

E-KH-1920

B-05425025460816

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Zentech s.a.
UDI-DI code: 05425025460816
Reference / catalog number: E-KH-1920

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View device family (Basic UDI)

Manufacturer information

Organization name: Zentech s.a.
SRN: BE-MF-000001650
Manufacturer status: Active

Critical warnings

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

CW096
H360FD: May damage fertility. May damage the unborn child.
CW073
EUDAMED did not publish a description for this code.
CW081
EUDAMED did not publish a description for this code.
CW084
EUDAMED did not publish a description for this code.
CW090
EUDAMED did not publish a description for this code.
CW103
EUDAMED did not publish a description for this code.
CW104
EUDAMED did not publish a description for this code.
CW044
EUDAMED did not publish a description for this code.
CW041
EUDAMED did not publish a description for this code.
CW045
EUDAMED did not publish a description for this code.

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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: 05425025460816
Basic UDI-DI: B-05425025460816
Reference / catalog number: E-KH-1920
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 Biotinidase Screening Assay is an enzymatic assay for the quantitative determination of biotinidase (BTD) activity levels. This device has been designed for neonates’ samples1, using dried blood spot on 903 or 226 filter paper2. This device is used by health professionals in a laboratory environment for biotinidase deficiency screening. The device 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
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05425025460816

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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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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.