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Skeletal Dynamics Single-Use Surgical Screwdrivers

by Skeletal Dynamics, Inc. EUDAMED

Active European Union

Ref DRVR-HCS-1015Model SDRVR-FAM

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08415061620667 Basic UDI-DIDate30 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
SDRVR-FAM, DRVR-HCS-1015
Primary DI / UDI-DI
00841506109213
Basic UDI-DI
08415061620667
EMDN Code
P091399 Orthopaedic implant instruments, single-use - other
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000041441
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

Other properties (13)

  • Sterile: No
  • 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