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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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UTM with nucleic acids preservation… — 3 UDI-DI variants, IVDR

MD Atlas
Copan Italia S.P.A.

Data from EUDAMED, last updated May 30, 2026

UTM with nucleic acids preservation claim

80533260BD0560AM004B6

3 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: Copan Italia S.P.A.

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 80533260BD0560AM004B6
Device name: UTM with nucleic acids preservation claim
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 26, 2026

Manufacturer & authorised representative

Manufacturer

Name: Copan Italia S.P.A.
SRN: IT-MF-000022535
Country: Italy
Email: regulatory.affairs@copangroup.com

Variants by status

UDI-DI variants

3 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KSHPZ6PZZH9EGBBBWJR6ZAEC

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

UTM18053326011556
UTM18053326011563
UTM18053326011808