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Class IIa Surgical Instruments

by Biotec S.R.L. Italy EUDAMED

Ref 530HS001Model DRIVER, SCREWDRIVER, WRENCH, IMPLANT DRIVER MINI HANDPIECE, DRILL EXTENSION

EMDN L159099

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Class IIa Surgical Instruments
Model / Reference
DRIVER, SCREWDRIVER, WRENCH, IMPLANT DRIVER MINI HANDPIECE, DRILL EXTENSION, 530HS001
Primary DI / UDI-DI
+D748530HS0010+
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED +D748530HS0010+|++D748ISODEVICES7W 61 fields · synced 24 Oct 2026