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Nexum dental intraoral scanner

by Shenzhen UP3D Tech Co., Ltd. EUDAMED

Active European Union

Ref iox 6.0Model UP610

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697545612UP610MH Basic UDI-DIDate26 Jan 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  • Withdrawn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
Intraoral Scanner
Model / Reference
UP610, iox 6.0
Primary DI / UDI-DI
06975456122023
Basic UDI-DI
697545612UP610MH
Direct Marketing DI
06975456122023
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000016969
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Shenzhen UP3D Tech Co., 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