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APrevent® VOIS Instrument

by APrevent Biotech GmbH Austria EUDAMED

Ref APT104Model APT100 EMDN L149099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000305808 Date30 Mar 2026IssuedStatusActive expires 26 Mar 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000305808 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    30 Mar 2026
    Expires
    26 Mar 2030
    Reason
    Add device or group

Specification

EUDAMED · synced 22 Oct 2026

Device Name
VOIS Instruments
Model / Reference
APT100, APT104
Primary DI / UDI-DI
09120117860210
Basic UDI-DI
912011786UTAHG
Direct Marketing DI
09120117860210
EMDN Code
L149099 ENT instruments, reusable - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000001435

Other devices from APrevent Biotech GmbH

See all devices from APrevent Biotech GmbH →

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 770aefdb-6ea0-4f01-a574-3847b13810e7 61 fields · synced 22 Oct 2026