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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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BioDye-4DS SYS — 2 UDI-DI variants, IVDR (Bioxol Kft)

MD Atlas
Bioxol Kft

Data from EUDAMED, last updated May 24, 2026

BioDye-4DS SYS

5999862176BioDye-4DSSYS59

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: Bioxol Kft

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 5999862176BioDye-4DSSYS59
Device name: —
Device model: BioDye-4DS SYS
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Feb 5, 2023

Manufacturer & authorised representative

Manufacturer

Name: Bioxol Kft
SRN: HU-MF-000025409
Country: Hungary
Email: hemat@bioxol.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01GRHCER4AVEAQP5Y65BFAQE2A

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

BioDye-4DS SYS WBC-5-diff fluorescent dye 3x42mL05999862176716
BioDye-4DS SYS WBC-5-diff fluorescent dye 42mL05999862176723