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ColdZyme

by Enzymatica AB EUDAMED

Active European Union

Ref 101010

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number73400311CZMSJE Basic UDI-DIDate25 Jun 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • EPT 0477.MDR.24/5405 Active

    Technical documentation EU MDR

    Notified body
    0477
    Issued
    7 Mar 2024
    Expires
    6 Mar 2029
  • EPT 0477.MDR.24/5406 Active

    Quality management system EU MDR

    Notified body
    0477
    Issued
    7 Mar 2024
    Expires
    6 Mar 2029

Specification

EUDAMED

Model / Reference
101010
Primary DI / UDI-DI
07340031105002
Basic UDI-DI
73400311CZMSJE
EMDN Code
Q0399 ENT devices - other
Device Class
Class III
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000002254

Other devices from Enzymatica AB

See all devices from Enzymatica AB →

Properties

  • Animal Tissues

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No