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by OsteoCare Implant System Limited United Kingdom EUDAMED

Ref IN-ISF-SM1Model Reusable Class 1r EMDN L150101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-50609129526634 Basic UDI-DIDate10 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
Reusable Class 1r, IN-ISF-SM1
Primary DI / UDI-DI
50609129526634
Basic UDI-DI
B-50609129526634
EMDN Code
L150101 Odontostomatology osteotomes, reusable
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000016843
Authorised representative
Advena Limited MT-AR-000000234

Other devices from OsteoCare Implant System Limited

See all devices from OsteoCare Implant System Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 0edd2ff2-aec9-4c53-9b0d-fad7d5a34638 61 fields · synced 25 Oct 2026