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Assufil Monofilamento P(La-Cl)

by Assut Europe SpA 35 variants

Ref FY033MGWAH

Active European Union

CE MDR

Valid until

7 Aug 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier ISTITUTO SUPERIORE DI SANITA'

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

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

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0013236626 Active Supplemented

    Quality management system EU MDR

    Issued
    28 Sep 2026
    Expires
    7 Aug 2028
    Reason
    Add device or group
  • CVD0034240124 Active Supplemented

    Technical documentation EU MDR

    Issued
    14 Oct 2024
    Expires
    7 Aug 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
FY033MGWAH
Primary DI / UDI-DI
38033439401585
Basic UDI-DI
8033439ASSUFILM-PLACLYC
Direct Marketing DI
38033439401585
EMDN Code
H010101010102 Mounted polydioxanone monofilament with needle for video surgery
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000018178

Other devices from Assut Europe SpA

  • Filbloc

    Class III
  • Assufil

    Class III
  • Darvin Lac

    Class III
  • Assufil Monofilamento

    Class III
  • Monofil Fast

    Class III
  • Assunyl

    Class III

See all devices from Assut Europe SpA →

Properties

  • 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