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3D Bond+

by Augma Biomaterials Ltd. EUDAMED

Active European Union

Ref 3D-ND-050

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3902867TD01 Date20 May 2026IssuedStatusActive expires 1 Feb 2030
European UnionCE/MDD NumberB-07290014838048 Basic UDI-DIDate15 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 3902867CE01 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    16 Feb 2025
    Expires
    1 Feb 2030
  • 3902867TD01 Amended

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    20 May 2026
    Expires
    1 Feb 2030
    Reason
    Other

Specification

EUDAMED

Device Name
Bond Apatite
Model / Reference
3D-ND-050
Primary DI / UDI-DI
07290014838048
Basic UDI-DI
B-07290014838048, 7290014838ABM5143YW
EMDN Code
Q010302 Dental graft devices
Device Class
Class III
Market of Registration
France

Manufacturer details

EUDAMED SRN
IL-MF-000020802
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Augma Biomaterials

See all devices from Augma Biomaterials →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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