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Monofil

by Assut Europe SpA 416 variants

Part of a family of 416 devices: see the family page

Ref FW515FWAH

Monofil (FW515FWAH) is a Class III device made by Assut Europe SpA, registered in EUDAMED on 8 Jun 2026 (Basic UDI-DI 8033439MONOFIL3T) with CE/MDR certificate CSQ0013236826 valid until 7 Aug 2028, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

7 Aug 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

3 certificates

Certifier ISTITUTO SUPERIORE DI SANITA'

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCSQ0013236826 Date26 Oct 2026IssuedStatusActive expires 7 Aug 2028

Official records

Certificates

3 certificates · EUDAMED

EUDAMED certificates (3)
  • CSQ0013236626 Active Supplemented Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    28 Sep 2026
    Expires
    7 Aug 2028
    Reason
    Add device or group
  • CSQ0013236826 Active Supplemented

    Quality management system EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    26 Oct 2026
    Expires
    7 Aug 2028
    Reason
    Add device or group
  • CVD0049250426 Active Supplemented

    Technical documentation EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    28 Sep 2026
    Expires
    7 Aug 2028
    Reason
    Add device or group

Timeline

5 dated events

  1. Registered EUDAMED 8033439MONOFIL3T
  2. Certificate issued EUDAMED CVD0049250426
  3. Certificate issued EUDAMED CSQ0013236826
  4. Certificate expires EUDAMED CSQ0013236826
  5. Certificate expires EUDAMED CVD0049250426

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
FW515FWAH
Primary DI / UDI-DI
38033439446081
Basic UDI-DI
8033439MONOFIL3T
Direct marketing DI
38033439446081
EMDN code
H010101010301 Poliglecaprone and derivatives monofilament with needle
Device class
Class III
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000018178

Similar devices in this category

Other devices filed under POLIGLECAPRONE AND DERIVATIVES MONOFILAMENT WITH NEEDLE.

Other devices from Assut Europe SpA

See all devices from Assut Europe SpA →

Properties

  • Supplied sterile
  • Implantable
Other properties (12, all answered No)