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OnX Tough 2 - Hollywood White - Multi-Unit Capsule 1-Pack

by Sprintray Inc.

Ref SRI-0204234

Active European Union

CE MDR

Valid until

29 Apr 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

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 Number1000318152 Date17 Aug 2026IssuedStatusActive expires 29 Apr 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000318152 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    17 Aug 2026
    Expires
    29 Apr 2030
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
OnX Tough 2
Model / Reference
SRI-0204234
Primary DI / UDI-DI
00810222900152
Basic UDI-DI
0850039704SRI-0202164HG
EMDN Code
Q0102050199 Dentistry resins - other
Device Class
Class IIa
EU 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