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Spline®

by ZimVie US Corp LLC United States EUDAMED

Ref 1845 EMDN Q0199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number844868A8H8 Basic UDI-DIDate21 May 2026RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Non-Sterile Dental Instruments
Model / Reference
1845
Primary DI / UDI-DI
00889024012875
Basic UDI-DI
844868A8H8
EMDN Code
Q0199 Odontology devices - other
Device Class
Class I
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 & raw data

Show properties, registry sources and raw records
  • Reusable
  • CMR Substance
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: 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 00889024012875|844868A8H8 61 fields · synced 25 Oct 2026