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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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Ziehl-Neelsen - Carbol Fuchsin -… — 3 UDI-DI variants, IVDR

MD Atlas
Cypress Diagnostics

Data from EUDAMED, last updated May 23, 2026

Ziehl-Neelsen - Carbol Fuchsin - Kühne's Methylene Blue

54040351HS00263

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: Cypress Diagnostics

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 54040351HS00263
Device name: Ziehl-Neelsen - Carbol Fuchsin - Kühne's Methylene Blue
Device model: HS002 - HS015 - HS016
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Nov 17, 2023

Manufacturer & authorised representative

Manufacturer

Name: Cypress Diagnostics
SRN: BE-MF-000000033
Country: Belgium
Email: cypress@diagnostics.be
Phone: +32 15 67 67 68

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01HFE7KKAC0QHER8SH3KDCY1CT

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

Carbol Fuchsin05404035100240
Kühne's Methylene Blue05404035100257
Ziehl-Neelsen05404035100233