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Flat Bottom Countersink Shaping Drill

by ZimVie US Corp LLC EUDAMED

Active European Union

Ref FCS485S

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number844868AMJG Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
Non sterile powered invasive instrument
Model / Reference
FCS485S
Primary DI / UDI-DI
00844868033776
Basic UDI-DI
844868AMJG
EMDN Code
L159099 Odontostomatology instruments, reusable - other
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000048255
Authorised representative
ZimVie Spain S.L.U. ES-AR-000000983

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • CMR Substance
  • Human Tissues

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No