Skip to content

Filbloc

by Assut Europe SpA 878 variants

Ref FP08GHHAE510(k) K150553

Active European Union and United States

CE MDR 510(k)

Valid until

7 Aug 2028

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

2 certificates

Certifier ISTITUTO SUPERIORE DI SANITA'

510(k) K150553↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberCSQ0013236626 Date28 Sep 2026IssuedStatusActive expires 7 Aug 2028
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK150553 Date19 May 2016ClearedStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0013236626 Active Supplemented

    Quality management system EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    28 Sep 2026
    Expires
    7 Aug 2028
    Reason
    Add device or group
  • CVD0014230224 Active Supplemented

    Technical documentation EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    12 Dec 2024
    Expires
    7 Aug 2028
    Reason
    Add device or group

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / Reference
FP08GHHAE
Primary DI / UDI-DI
18033439183838
Basic UDI-DI
8033439FILBLOCPDOV7
Direct Marketing DI
18033439183838
EMDN Code
H010101010104 Mounted polydioxanone monofilament with needle for tissue traction (‘barbed’)
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000018178
FDA applicant
Assut Europe

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