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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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Fiksativi — 53 UDI-DI variants, IVDR (BioGnost Ltd.)

MD Atlas
BioGnost Ltd.

Data from EUDAMED, last updated May 24, 2026

Fiksativi

385889212HPC30705FIXAQX

53 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: 385889212HPC30705FIXAQX
Device name: Fiksativi
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 16, 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

53 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01G2YSY6HXR5SA77S1HC8A0H67

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

10% Formaldehyde, 10 L03858890007756
10% Formaldehyde, 5 L03858890007763
10% Formaldehyde, 1 L03858888828738
10% Formaldehyde, 20 L03858890007749
10% NB Formaldehyde, 1 L03858888820169
10% NB Formaldehyde, 10 L03858888820190
10% NB Formaldehyde, 20 L03858888820206
10% NB Formaldehyde, 5 L03858888820183
4% Formaldehyde, 1 L03858888828943
4% Formaldehyde, 10 L03858890007725
4% Formaldehyde, 20 L03858890007732
4% Formaldehyde, 5 L03858892124178
4% NB Formaldehyde, 1 L03858888820114
4% NB Formaldehyde, 10 L03858888820145
4% NB Formaldehyde, 20 L03858888820152
4% NB Formaldehyde, 5 L03858888820138
BioFix C, 1 L03858890005745
BioFix C, 5 L03858890006957
BioFix C, 500 mL03858890007688
BioFix HD, 1 L03858890003543
BioFix HD, 5 L03858892121702
BioFix HD, 500 mL03858890003536
BioFix, 1 L03858890007770
BioFix, 500 mL03858888829803
BioForm S, 1 L03858888821517

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