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Freehand ZOOM Module

by MediAkris, razvoj in proizvodnja medicinskih naprav, d.o.o.

Ref 50449021

Active European Union

CE MDR

Valid until

29 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

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 Number383008873ZOOM01KK Basic UDI-DI 03830088730028UDI-DIDate4 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
50449021
Primary DI / UDI-DI
03830088730028
Basic UDI-DI
383008873ZOOM01KK
EMDN Code
Z12020185 Remote control robot-assisted endoscopic surgery instruments - consumables
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
SI-MF-000048191

Other devices from MediAkris, razvoj in proizvodnja medicinskih naprav, d.o.o.

Properties

  • Sterile

Other properties (12)

  • 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