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Reusable Tip of Intraoral Scanner

by Changzhou Sifary Medical Technology Co., Ltd. 14 variants

Ref 7680021Model Helios 500 Size S, Helios 500 Size L

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697259778EM004MN Basic UDI-DI 06975132957536UDI-DIDate17 Jul 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Helios 500 Size S, Helios 500 Size L, 7680021
Primary DI / UDI-DI
06975132957536
Basic UDI-DI
697259778EM004MN
EMDN Code
Q010280 Prosthetic dentistry devices - accessories
Device Class
Class I
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000010405
Authorised representative
Caretechion GmbH DE-AR-000005946

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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