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Glycolon®

by Advanced Medical Solutions (France) SAS

Ref SX204

Active European Union

CE MDR

Valid until

4 Sep 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 835938 Date15 Sep 2026IssuedStatusActive expires 4 Sep 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 835938 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Sep 2026
    Expires
    4 Sep 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
GLYCOLON® and GLYCOLON® ORAL / MONOGLYC™ / creos™ glycostitch
Model / Reference
SX204
Primary DI / UDI-DI
03661522104842
Basic UDI-DI
3661522TDSU3601XY
EMDN Code
H010101010301 Poliglecaprone and derivatives monofilament with needle
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
FR-MF-000000666

Other devices from Advanced Medical Solutions (France) SAS

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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