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Assufil Monofilamento FV516M

by Assut Europe SpA

Ref FV516M

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

7 Aug 2028

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

2 certificates

Certifier ISTITUTO SUPERIORE DI SANITA'

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberCSQ0013236626 Date28 Sep 2026IssuedStatusActive expires 7 Aug 2028
United StatesGUDID listing GUDID Number18033439398553 UDI-DI Date13 Aug 2018ListedStatusListed GUDID: in commercial distribution

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
  • CVD0031240425 Active Supplemented

    Technical documentation EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    11 Sep 2025
    Expires
    7 Aug 2028
    Reason
    Add device or group

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Assufil Monofilamento
Generic Name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Model / Reference
FV516M
Primary DI / UDI-DI
18033439398553 EUDAMED
08033439005195 GUDID
Basic UDI-DI
8033439ASSUFILM-PDOUG
Direct Marketing DI
18033439398553
510(k) Number
FDA Product Code
NEW
EMDN Code
H010101010101 Polydioxanone monofilament with needle for open surgery
GMDN Term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
878.4840
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
18033439398553
GUDID
08033439005195
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Cleared under the same submission (K150553)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No