Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

E-KR-576 — IVDD — General IVDD by Zentech s.a.

MD Atlas
Zentech s.a.

EUDAMED last updated this device on Apr 23, 2026

E-KR-576

B-05425025460083

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: 05425025460083
Reference / catalog number: E-KR-576

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?

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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

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: 05425025460083
Basic UDI-DI: B-05425025460083
Reference / catalog number: E-KR-576
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 IRT Screening ELISA is an enzyme immunoassay for the quantitative determination of immunoreactive trypsinogen (IRT). 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 cystic fibrosis 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)05425025460083

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

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

W0102019007IMMUNO REACTIVE TRYPSIN

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Become a partner of MD Atlas