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S10

by Fussen Imaging Co., Ltd. EUDAMED

Active European Union

Ref S10Model S6500, S10, S10P Wireless, S10L Wireless, S10E Wireless, S10D Wireless

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697763564S10UW Basic UDI-DIDate10 Jun 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  • Withdrawn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
Digital Intraoral Scannner System
Model / Reference
S6500, S10, S10P Wireless, S10L Wireless, S10E Wireless, S10D Wireless
Primary DI / UDI-DI
06977635640014
Basic UDI-DI
697763564S10UW
EMDN Code
Z12119099 Various dental stomatology instruments - other
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000047718
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Fussen Imaging 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