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Bio GP Points

by Sure Dent Corporation United States EUDAMED

Ref G912 B15-40/.02

EMDN Q01010401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880926429GP2D Basic UDI-DIDate7 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Gutta Percha Points
Model / Reference
G912 B15-40/.02
Primary DI / UDI-DI
08809264291559
Basic UDI-DI
880926429GP2D
Direct Marketing DI
08809264291559
EMDN Code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000018662
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Sure Dent Corporation

See all devices from Sure Dent Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Implantable
Other properties (12)
  • Sterile: 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

Sources (1)

  • EUDAMED 08809264291559|880926429GP2D 61 fields · synced 25 Oct 2026