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ROYAL GRANULES - 3x3x3 mm – Qty. 5cc

by Teknimed SAS

Ref RM824402Model Synthetic Bone Substitute

Active European Union

CE MDR

Valid until

11 Aug 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376017704B10CT Basic UDI-DI 03760177044227UDI-DIDate22 Oct 2024RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 737954 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    12 Aug 2024
    Expires
    11 Aug 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Triha+
Model / Reference
Synthetic Bone Substitute, RM824402
Primary DI / UDI-DI
03760177044227
Basic UDI-DI
376017704B10CT
EMDN Code
P900401 Bone and tendon replacement devices
Device Class
Class III
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000001224

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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