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

MD Atlas
Zentech s.a.

EUDAMED last updated this device on Apr 23, 2026

E-GQ-1920

B-05425025460557

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: 05425025460557
Reference / catalog number: E-GQ-1920

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View device family (Basic UDI)

Manufacturer information

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

Related devices

J-LS-96PartBB-05425025461165On the market E-KH-1920B-05425025460816On the market I-MD-576B-05425025461110On the market I-ME-576B-05425025461127On the market J-LS-480PartAB-05425025460007On 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

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

CW083
EUDAMED did not publish a description for this code.
CW089
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.
CW044
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: 05425025460557
Basic UDI-DI: B-05425025460557
Reference / catalog number: E-GQ-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 ELIZEN Neonatal 17-OHP Screening is an enzyme immunoassay for the quantitative determination of 17-alpha-hydroxyprogesterone (17 OHP). This device 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 congenital adrenal hyperplasia screening. The device should not be used for confirmatory testing. The kit can be used manually or with an automate.
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)05425025460557

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EMDN nomenclature code(s)

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

W010205010717 OH PROGESTERONE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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