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Class IIa Surgical Instruments

by Biotec S.R.L. EUDAMED

Active European Union

Ref 520HS004Model DRIVER, SCREWDRIVER, WRENCH, IMPLANT DRIVER MINI HANDPIECE, DRILL EXTENSION

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D748ISODEVICES7W Basic UDI-DIDate30 Jan 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Class IIa Surgical Instruments
Model / Reference
DRIVER, SCREWDRIVER, WRENCH, IMPLANT DRIVER MINI HANDPIECE, DRILL EXTENSION, 520HS004
Primary DI / UDI-DI
+D748520HS00400
Basic UDI-DI
++D748ISODEVICES7W
EMDN Code
L159099 Odontostomatology instruments, reusable - other
Device Class
Class IIa
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

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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