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OnX Tough 2 - Hollywood White - Multi-Unit Capsule 3-Pack

by Sprintray Inc. EUDAMED

Active European Union

Ref SRI-0204201

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850039704SRI-0202164HG Basic UDI-DIDate6 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000318152 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    17 Aug 2026
    Expires
    29 Apr 2030
    Reason
    Add device or group

Specification

EUDAMED

Device Name
OnX Tough 2
Model / Reference
SRI-0204201
Primary DI / UDI-DI
00810222900183
Basic UDI-DI
0850039704SRI-0202164HG
EMDN Code
Q0102050199 Dentistry resins - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000036081
Authorised representative
SprintRay Europe GmbH DE-AR-000033436

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Properties

  • CMR Substance

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No