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Assufil Fast

by Assut Europe SpA Italy EUDAMED

Ref FU246RAT

EMDN H010101020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033439ASSUFILFASTZM Basic UDI-DIDate5 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0013236626 Supplemented

    Quality management system EU MDR

    Notified body
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    28 Sep 2026
    Expires
    7 Aug 2028
    Reason
    Add device or group
  • CVD003624 Issued

    Technical documentation EU MDR

    Notified body
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    28 Oct 2024
    Expires
    7 Aug 2028

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
FU246RAT
Primary DI / UDI-DI
38033439424553
Basic UDI-DI
8033439ASSUFILFASTZM
Direct Marketing DI
38033439424553
EMDN Code
H010101020101 Polyglycolic acid multifilament with needle for open surgery
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000018178

Other devices from Assut Europe SpA

See all devices from Assut Europe SpA →

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 38033439424553|8033439ASSUFILFASTZM 61 fields · synced 24 Oct 2026