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SDC G5-ProLign 0.1 mm two sides / 1 pc

by Swissdentacare SA EUDAMED

Active European Union

Ref 1310/1U, 1340/5, 1320/3, DEMO-KIT, 1300/S2, 1300/S6, 1300/S7-JP, 1300/S5-JP, 1320-1/5, 1300-KIT-NSK-X55L, 1330/1U, 1310/3, 1330/3, 1310-1/3, 1300-KIT-COXO COURSE, FS-120-KIT, 1310/5

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764035775_G5-ProLign_84 Basic UDI-DIDate29 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Trade Name
SDC G5-ProLign 0.1 mm two sides / 1 pc
SDC G5-ProLign 0.4 mm two sides / 5 pcs
SDC G5-ProLign 0.2 mm two sides / 3 pcs
SDC G5-ProLign Set two sides 0.2 - 0.3 mm
SDC G5-ProLign Set all two sides + G5-UltraSoft
SDC G5-ProLign Set all one & two sides
SDC G5-ProLign Set all two sides
SDC G5-ProLign 0.2 mm one side / 5 pcs
SDC G5-ProLign 0.3 mm two sides / 1 pc
SDC G5-ProLign 0.1 mm two sides / 3 pcs
SDC G5-ProLign 0.3 mm two sides / 3 pcs
SDC G5-ProLign 0.1 mm one side / 3 pcs
SDC-Ortho Fix&Strip Starter Kit
SDC G5-ProLign 0.1 mm two sides / 5 pcs
Device Name
Swissdentacare G5-ProLign
Model / Reference
1310/1U, 1340/5, 1320/3, DEMO-KIT, 1300/S2, 1300/S6, 1300/S7-JP, 1300/S5-JP, 1320-1/5, 1300-KIT-NSK-X55L, 1330/1U, 1310/3, 1330/3, 1310-1/3, 1300-KIT-COXO COURSE, FS-120-KIT, 1310/5
Primary DI / UDI-DI
07640357750284, 07640357750925, 07640357750338, 07640357750802, 07640357750154, 07640357750208, 07640357750222, 07640357750192, 07640357750901, 07640357750277, 07640357750369, 07640357750291, 07640357750376, 07640357750314, 07640357750239, 07640357750826, 07640357750871
Basic UDI-DI
764035775_G5-ProLign_84
Direct Marketing DI
07640357750802
07640357750277
07640357750239
EMDN Code
Q01010199,Q010499
Device Class
Class IIa
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