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Darvin Lac

by Assut Europe SpA Italy EUDAMED

Ref 06DDPLAH

EMDN H010101020202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033439GLICOFILLACJ2 Basic UDI-DIDate2 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • 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
  • CVD0050250126 Supplemented

    Technical documentation EU MDR

    Issued
    23 Mar 2026
    Expires
    7 Aug 2028
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Glicofil Lac
Model / Reference
06DDPLAH
Primary DI / UDI-DI
38033439461503
Basic UDI-DI
8033439GLICOFILLACJ2
Direct Marketing DI
38033439461503
EMDN Code
H010101020202 Polyglycolic with lactic acid multifilament with needle for video surgery
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 38033439461503|8033439GLICOFILLACJ2 61 fields · synced 24 Oct 2026