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Surgical instruments

by Biotec S.R.L. EUDAMED

Active European Union

Ref 453HR420, 435KR001.02, 435VR001.02, 435KT001.02, 435IR001.02, 435KR002.02, 435KW001.02Model BONE PROFILER, DRILL, SCREW TAP, TISSUE PUNCH, COUNTERSINK, GUIDE

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D748DRILLTAPMU6N Basic UDI-DIDate31 Jan 2023RegisteredStatusActive

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  • Withdrawn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
Surgical instruments
Guide
Model / Reference
BONE PROFILER, DRILL, SCREW TAP, TISSUE PUNCH, COUNTERSINK, 453HR420, GUIDE, 435KR001.02, 435VR001.02, 435KT001.02, 435IR001.02, 435KR002.02, 435KW001.02
Primary DI / UDI-DI
+D748453HR42006, +D748435KR0010206, +D748435VR001020H, +D748435KT0010208, +D748435IR0010204, +D748435KR0020207, +D748435KW001020B
Basic UDI-DI
++D748DRILLTAPMU6N, ++D748GUIDESDEVS3R
EMDN Code
L159099, Z12119099
Device Class
Class IIa
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026774

Other devices from Biotec S.R.L.

See all devices from Biotec S.R.L. →

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