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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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BIOHIT FAEX Sample System — 2 UDI-DI variants, IVDR (Biohit Oyj)

MD Atlas
Biohit Oyj

Data from EUDAMED, last updated May 23, 2026

BIOHIT FAEX Sample System

6419587BFX010TC

2 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: Biohit Oyj

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 6419587BFX010TC
Device name: BIOHIT FAEX Sample System
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Jan 30, 2025

Manufacturer & authorised representative

Manufacturer

Name: Biohit Oyj
SRN: FI-MF-000014642
Country: Finland
Email: info@biohit.fi
Phone: +358 9 773 861

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01JJVWRF6YPBNT43K23YZDXT66

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

BIOHIT FAEX Sample System06419587349008
BIOHIT FAEX Sample System06419587348001