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GenTek®

by Zfx GmbH EUDAMED

Active European Union

Ref ZFX05I-ZB-TSV-35, ZFX05I-ZB-EX-4160, ZFX05I-ZB-TA-45, ZFX05I-ZB-LP-48, ZFX05I-ZB-CE-4160, ZFX05I-ZB-LP-48-NE, ZFX05I-ZB-TSV-45, ZFX05I-ZB-EZ-29, ZFX05I-ZB-EX-34

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42518817-GT-I-Scanbody-J2 Basic UDI-DIDate13 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
GenTek® Intraoral Scanbody
Model / Reference
ZFX05I-ZB-TSV-35, ZFX05I-ZB-EX-4160, ZFX05I-ZB-TA-45, ZFX05I-ZB-LP-48, ZFX05I-ZB-CE-4160, ZFX05I-ZB-LP-48-NE, ZFX05I-ZB-TSV-45, ZFX05I-ZB-EZ-29, ZFX05I-ZB-EX-34
Primary DI / UDI-DI
04251881768749, 04251881768596, 04251881768718, 04251881768657, 04251881768534, 04251881768688, 04251881768770, 04251881768626, 04251881768565
Basic UDI-DI
42518817-GT-I-Scanbody-J2
EMDN Code
Q01010199 Dental restoration devices - other
Device Class
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000018101

Other devices from Zfx GmbH

See all devices from Zfx GmbH →

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