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Single-use drill bit

by SI-BONE, Inc. EUDAMED

Active European Union

Ref 400426-002

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081005552Drillbit2T Basic UDI-DIDate9 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Single-use drill bit
Model / Reference
400426-002
Primary DI / UDI-DI
00810055523047
Basic UDI-DI
081005552Drillbit2T
Direct Marketing DI
00810055523047
EMDN Code
P091303 Orthopaedic implant drill bits, single-use
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000028624
Authorised representative
ICON (LR) Limited IE-AR-000006507

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Properties

  • Sterile

Other properties (12)

  • Implantable: 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