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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 hematologiju — 77 UDI-DI variants, IVDR (BioGnost Ltd.)

MD Atlas
BioGnost Ltd.

Data from EUDAMED, last updated May 24, 2026

Reagensi za hematologiju

385889212HPC3010302HMCA

77 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: 385889212HPC3010302HMCA
Device name: Reagensi za hematologiju
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 23, 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

77 UDI-DI variants

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Applied filters

basicUdiUlid01G3NSSTWRQ7AP4AZWS9BVR68A

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

Buffer solution, pH 6.4, 5000 mL03858892121979
Buffer solution, pH 6.8, 1000 mL03858890007183
Buffer solution, pH 6.8, 2500 mL03858890007213
Buffer solution, pH 6.8, 2500 mL03858892121986
Buffer solution, pH 7.2, 1000 mL03858892120651
Buffer solution, pH 7.2, 2500 mL03858892121993
Buffer solution, pH 7.2, 5000 mL03858892122006
Buffer tablets pH 6.8, 100 pcs03858888822538
Buffer tablets pH 6.8, 50 pcs03858890009170
Buffer tablets pH 7.2, 100 pcs03858888822545
Buffer tablets pH 7.2, 50 pcs03858890004632
CytoGnost kit, 3x100 mL03858892124062
CytoGnost kit, 3x1000 mL03858892124598
CytoGnost kit, 3x500 mL03858892124581
Field kit, 2x1 L03858892122198
Field kit, 2x500 mL03858890009132
Field kit, for 100 tests03858890006698
Giemsa solution, 100 mL03858888822095
Giemsa solution, 1000 mL03858888822118
Giemsa solution, 10x100 mL03858888829018
Giemsa solution, 20 L03858890001723
Giemsa solution, 2500 mL03858888829919
Giemsa solution, 500 mL03858888822101
Hayem's solution, 100 mL03858888822125
Hayem's solution, 1000 mL03858890009194

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