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Steri Case - Electric Heka System

by Zethon Ltd

Ref 103610

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 Number50605201INT08MAN13YP Basic UDI-DI 05059358036761UDI-DIDate23 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  • Withdrawn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

Device Name
Steri Case - Electric Heka System
Model / Reference
103610
Primary DI / UDI-DI
05059358036761
Basic UDI-DI
50605201INT08MAN13YP
Direct Marketing DI
05059358036761
EMDN Code
Z12011301 Cleaning and disinfection equipment
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000014309
Authorised representative
De Soutter Medical Limited NL-AR-000000438

Other devices from Zethon Ltd

See all devices from Zethon 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