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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 citokemiju — 17 UDI-DI variants, IVDR (BioGnost Ltd.)

MD Atlas
BioGnost Ltd.

Data from EUDAMED, last updated May 24, 2026

Reagensi za citokemiju

385889212HPC30702CYTOS9

17 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: 385889212HPC30702CYTOS9
Device name: Reagensi za citokemiju
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 24, 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

17 UDI-DI variants

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Applied filters

basicUdiUlid01G3VN8R739YYVN75EP96P5A0T

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

LeukoGnost ACP, for at least 50 tests03858892122440
LeukoGnost ALP, for at least 100 tests03858892122433
LeukoGnost Fixative ECO, 500 mL03858892124543
LeukoGnost Fixative GL, 500 mL03858892123126
LeukoGnost Fixative, 500 mL03858892132401
LeukoGnost HEM, 100 mL03858892123492
LeukoGnost HEM, 250 mL03858892124550
LeukoGnost HEM, 500 mL03858892123713
LeukoGnost MPO, for at least 100 tests03858892122426
LeukoGnost NSE, for at least 100 tests03858892122464
LeukoGnost PAS, for at least 100 tests03858892122471
LeukoGnost PERLS, for 100 tests03858892124451
LeukoGnost PLUS, for at least 100 tests03858892123850
LeukoGnost SPE, for at least 100 tests03858892122457
LeukoGnost SPENSE, for at least 50 tests03858892123409
Sudan Black B ECO, for 100 tests03858892123508
Sudan Black B kit, for 350-400 tests03858890001877