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SDC G5-UltraSoft 6 µm two sides / 1 pc

by Swissdentacare SA

Ref 1106/1U, 1106/3

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 linked in EUDAMED

A group certificate may exist

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 Number764035775_G5-UltraSoft_W4 Basic UDI-DI Date29 Sep 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Trade Name
SDC G5-UltraSoft 6 µm two sides / 1 pc
SDC G5-UltraSoft 6 µm two sides / 3 pcs
Device Name
Swissdentacare G5-UltraSoft
Model / Reference
1106/1U, 1106/3
Primary DI / UDI-DI
07640357750079, 07640357750086
Basic UDI-DI
764035775_G5-UltraSoft_W4
EMDN Code
Q01010199, Q010499
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CH-MF-000016591
Authorised representative
SDC Distribution GmbH DE-AR-000014065

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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