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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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KENZA 450TX — 3 UDI-DI variants, IVDR (BIOLABO)

MD Atlas
BIOLABO

Data from EUDAMED, last updated May 19, 2026

KENZA 450TX

376017308K4R5

3 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class A

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: BIOLABO

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 376017308K4R5
Device name: KENZA 450TX
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Aug 30, 2023

Manufacturer & authorised representative

Manufacturer

Name: BIOLABO
SRN: FR-MF-000001633
Country: France
Email: support@biolabo.fr

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01H93694M5HQ6J09SZ5QHWSAEN

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

KENZA 450ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, including accessories03760173087211
KENZA 450TX - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories03760173087204
SERUM CUPS K45003760173087273