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New-Fill

by Q-Med AB Sweden EUDAMED

Ref 085883Model New-Fill

EMDN P900402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number73316890148X Basic UDI-DIDate1 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2268181TD02 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    3 Dec 2025
    Expires
    1 Dec 2030
  • 2268181CE02 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    3 Dec 2025
    Expires
    1 Aug 2030

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
New-Fill, 085883
Primary DI / UDI-DI
07331689858839
Basic UDI-DI
73316890148X
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Market of Registration
France

Manufacturer details

EUDAMED SRN
SE-MF-000008549

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • 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 b16a1ed1-2cc5-40ac-8206-a3ba43cfea38 61 fields · synced 22 Oct 2026