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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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ColdZyme — 9 UDI-DI variants, MDR (Enzymatica AB)

MD Atlas
Enzymatica AB

Data from EUDAMED, last updated May 30, 2026

ColdZyme

73400311CZMSJE

9 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class III

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Manufacturer: Enzymatica AB

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Device characteristics

Animal tissues / cells

Legacy certificates

Certificate number: EPT 0477.MDR.24/5406
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: Eurofins Product Testing Italy S.r.l. (0477)
Validity: Mar 7, 2024 → Mar 6, 2029

Certificate number: EPT 0477.MDR.24/5405
Type: refdata.certificate-mdr-type.technical-documentation
Notified body: Eurofins Product Testing Italy S.r.l. (0477)
Validity: Mar 7, 2024 → Mar 6, 2029

Identity & classification

Basic UDI-DI: 73400311CZMSJE
Device name: ColdZyme
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Version date: Jun 25, 2024

Manufacturer & authorised representative

Manufacturer

Name: Enzymatica AB
SRN: SE-MF-000002254
Country: Sweden
Email: info@enzymatica.se
Phone: +46 46 286 31 00

Variants by status

UDI-DI variants

9 UDI-DI variants

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Applied filters

basicUdiUlid01J17AE2A4BV8SXSPAEG5PVDGK

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

10101007340031105002
ColdZyme07340031105019
ColdZyme07340031106016
10111507340031106009
ColdZyme07340031105040
10170107340031108515
10130107340031108010
10120207340031107006
10101507340031105132