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NeoBurr

by Microcopy, A Division of Neo-Flo, Inc. United States EUDAMED

Ref HP.TC563L

EMDN Z12110102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08402216NBSMUDP Basic UDI-DIDate26 May 2026RegisteredStatusActive

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
Tungsten carbide Burs – Pre-Sterile
Model / Reference
HP.TC563L
Primary DI / UDI-DI
00840221667589
Basic UDI-DI
08402216NBSMUDP
EMDN Code
Z12110102 Dental drills
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000012637
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Microcopy, A Division of Neo-Flo, Inc.

See all devices from Microcopy, A Division of Neo-Flo, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 00840221667589|08402216NBSMUDP 61 fields · synced 24 Oct 2026