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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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Fixatives, decalcifier, formalin… — 24 UDI-DI variants, IVDR

MD Atlas
Bio-Optica Milano S.p.A.

Data from EUDAMED, last updated May 30, 2026

Fixatives, decalcifier, formalin prefilled

080339762W01030705X2

24 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: Bio-Optica Milano S.p.A.

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Device characteristics

Reagent

Identity & classification

Basic UDI-DI: 080339762W01030705X2
Device name: Fixatives, decalcifier, formalin prefilled
Device model: Fixatives, decalcifiers, formalin prefilled
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Nov 4, 2022

Manufacturer & authorised representative

Manufacturer

Name: Bio-Optica Milano S.p.A.
SRN: IT-MF-000027525
Country: Italy
Email: info@bio-optica.it

Variants by status

UDI-DI variants

24 UDI-DI variants

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Applied filters

basicUdiUlid01GH1CP9VMQ3D4Y7PADNGSMM1W

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% neutral buffered formalin (ready to use)08033976231958
10% neutral buffered formalin (ready to use)08033976234096
10% neutral buffered formalin (ready to use)08033976231934
10% neutral buffered formalin (ready to use)08033976231910
10% neutral buffered formalin (ready to use)08033976231989
10% neutral buffered formalin (ready to use)08033976231576
10% neutral buffered formalin (ready to use)08033976232023
10% neutral buffered formalin (ready to use)08033976231880
10% neutral buffered formalin (ready to use)08033976232016
10% neutral buffered formalin (ready to use)08033976231972
10% neutral buffered formalin (ready to use)08033976232009
10% neutral buffered formalin (ready to use)08033976234157
10% neutral buffered formalin (ready to use)08033976231903
10% saline Formalin - ready to use solution08033976231705
Acid phopshatase fixative08033976238704
05-M0102308033976234362
30-3011108033976238612
05-X20008033976235079
05-M0100808033976234331
Decalcifier-Fixative Gooding Stewart08033976232085
05-M0102408033976234379
Formaldehyde solution 38-40%08033976234133
04-23082708033976231521
Neutral buffered Formalin (concentrated solution)08033976234119