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3E-Zyme

by Medisafe UK Ltd 4 variants

Ref MED8035Model 3E-Zyme

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0724995MD3EZYME2W Basic UDI-DI 05060247260471UDI-DIDate2 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
3E-Zyme, MED8035
Primary DI / UDI-DI
05060247260471
Basic UDI-DI
0724995MD3EZYME2W
EMDN Code
D99 Disinfectants, antiseptics, sterilising agents and detergents for medical devices - other
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000019466
Authorised representative
STERIS Ireland Ltd IE-AR-000010065

Other devices from Medisafe UK Ltd.

See all devices from Medisafe UK Ltd. →

Properties

Other properties (13)

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