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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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Reagensi za mikrobiologiju — 145 UDI-DI variants, IVDR

MD Atlas
BioGnost Ltd.

Data from EUDAMED, last updated May 24, 2026

Reagensi za mikrobiologiju

385889212HPC4080299MCKA

145 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: BioGnost Ltd.

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 385889212HPC4080299MCKA
Device name: Reagensi za mikrobiologiju
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 25, 2022

Manufacturer & authorised representative

Manufacturer

Name: BioGnost Ltd.
SRN: HR-MF-000022153
Country: Croatia
Email: ivan.marchiotti@biognost.hr
Phone: +38512409997

Variants by status

UDI-DI variants

145 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01G3XMX9ZYYYMHA4DHM7GK358K

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

TB-Stain Auramine O kit, 4x250 mL03858890009750
TB-Stain Auramine O kit, 4x500 mL03858890009767
TB-Stain Cold kit, 4x100 mL03858888820473
TB-Stain Cold kit, 4x250 mL03858888820480
TB-Stain Cold kit, 4x500 mL03858888820497
TB-Stain Cold kit, for 100 tests03858890005899
TB-Stain ECO kit, 4x100 mL03858892122570
TB-Stain ECO kit, 4x250 mL03858892122587
TB-Stain ECO kit, 4x500 mL03858892122594
TB-Stain Fluorescent kit, 4x100 mL03858888820510
TB-Stain Fluorescent kit, 4x250 mL03858888820527
TB-Stain Fluorescent kit, 4x500 mL03858888820534
TB-Stain Fluorescent kit, for 100 tests03858890007114
TB-Stain Hot kit, 4x100 mL03858888820435
TB-Stain Hot kit, 4x250 mL03858888820442
TB-Stain Hot kit, for 100 tests03858890006186
TBH-K-50003858888820459
TB-Stain Quick kit, 3x100 mL03858892121405
TB-Stain Quick kit, 3x250 mL03858892122013
TB-Stain Quick kit, 3x500 mL03858892122020

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