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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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Popratni reagensi za imunohistokemijsko… — 10 UDI-DI variants, IVDR

MD Atlas
BioGnost Ltd.

Data from EUDAMED, last updated May 24, 2026

Popratni reagensi za imunohistokemijsko bojenje

385889212HPC30711AIHCMH

10 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: 385889212HPC30711AIHCMH
Device name: Popratni reagensi za imunohistokemijsko bojenje
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Aug 10, 2023

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

10 UDI-DI variants

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Applied filters

basicUdiUlid01H7FFWN225P4BZVPX22WEKB0A

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

DAB Chromogen kit, for 1250 tests03858892125434
DAB Chromogen kit, for 250 tests03858892125427
One Step HRP Detection System, for 100 tests03858892125502
One Step HRP Detection System, for 250 tests03858888824099
One Step Polymer HRP, for 1250 tests, 125 mL03858892125465
One Step Polymer HRP, for 250 tests, 25 mL03858892125458
Two Step HRP Detection System, for 100 tests03858892125526
Two Step HRP Detection System, for 250 tests03858888824037
Two Step Polymer HRP, for 1250 tests03858892125489
Two Step Polymer HRP, for 250 tests03858892125472