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Darvin Lac

by Assut Europe SpA 210 variants

Part of a family of 745 devices: see the family page

Ref DB795KLAH

Darvin Lac (DB795KLAH) is a Class III device made by Assut Europe SpA, registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 8033439GLICOFILLACJ2) 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
  • CVD0050250126 Active Supplemented

    Technical documentation EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    23 Mar 2026
    Expires
    7 Aug 2028
    Reason
    Change approved

Timeline

5 dated events

  1. Certificate issued EUDAMED CVD0050250126
  2. Registered EUDAMED 8033439GLICOFILLACJ2
  3. Certificate issued EUDAMED CSQ0013236826
  4. Certificate expires EUDAMED CSQ0013236826
  5. Certificate expires EUDAMED CVD0050250126

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Glicofil Lac
Model / reference
DB795KLAH
Primary DI / UDI-DI
38033439461015
Basic UDI-DI
8033439GLICOFILLACJ2
Direct marketing DI
38033439461015
EMDN code
H010101020202 Polyglycolic with lactic acid multifilament with needle for video surgery
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 POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT.

Other devices from Assut Europe SpA

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Properties

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