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PInPoint System

by Aktina Medical Corp United States EUDAMED

Ref 50-455Model PInPoint System

EMDN Z11010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B365505XXPinPointSys6J Basic UDI-DIDate7 Oct 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Vacuum Fixation Mouthpiece, Small (10 pack)
Model / Reference
PInPoint System, 50-455
Primary DI / UDI-DI
+B365504551
Basic UDI-DI
++B365505XXPinPointSys6J
Direct Marketing DI
+B365504551
EMDN Code
Z11010199 Linear accelerators – other
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000005935
Authorised representative
European Healthcare & Device Solutions Ltd. IE-AR-000003999

Other devices from Aktina Medical Corp

See all devices from Aktina Medical Corp →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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 83dcef62-9c21-48de-9dc8-3569ae93d8a0 61 fields · synced 22 Oct 2026