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Assufil Monofilamento

by Assut Europe SpA Italy EUDAMED

Ref 02FRPMSAT EMDN H010101010103

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCSQ0013236626 Date28 Sep 2026IssuedStatusActive expires 7 Aug 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0013236626 Supplemented

    Quality management system EU MDR

    Issued
    28 Sep 2026
    Expires
    7 Aug 2028
    Reason
    Add device or group
  • CVD0031240425 Supplemented

    Technical documentation EU MDR

    Issued
    11 Sep 2025
    Expires
    7 Aug 2028
    Reason
    Add device or group

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
02FRPMSAT
Primary DI / UDI-DI
18033439379866
Basic UDI-DI
8033439ASSUFILM-PDOUG
Direct Marketing DI
18033439379866
EMDN Code
H010101010103 Polydioxanone monofilament without needle
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 cdf67acd-3aff-4452-9861-6692b77e21cc 61 fields · synced 24 Oct 2026