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Zfx® Intraoral Scanbody

by Zfx GmbH 39 variants

Ref ZFX05I-BH-IN-30-H4

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42518817-AM-I-Scanbody-YW Basic UDI-DI 04251881762143UDI-DIDate13 Apr 2026RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Zfx® Intraoral Scanbody
Model / Reference
ZFX05I-BH-IN-30-H4
Primary DI / UDI-DI
04251881762143
Basic UDI-DI
42518817-AM-I-Scanbody-YW
EMDN Code
Q01010199 Dental restoration devices - other
Device Class
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000018101

Related devices

Category: Dental appliance fabrication material, ceramic

Other devices from Zfx GmbH

See all devices from Zfx GmbH →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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