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Setiomer

by Semikal Teknoloji San. ve Tic. A.Ş. Türkiye EUDAMED

Ref AB215

EMDN M0406

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08684771343164 Basic UDI-DIDate12 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
SETIOMER Adhesion Barrier Gel
SETIOMER Anti-adhesion Gel
Model / Reference
AB215
Primary DI / UDI-DI
08684771343164, 08682190074812
Basic UDI-DI
B-08684771343164, B-08682190074812
EMDN Code
M0406 Dressings for the prevention of post-operative adhesions
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000024212

Other devices from Semikal Teknoloji San. ve Tic. A.Ş.

See all devices from Semikal Teknoloji San. ve Tic. A.Ş. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED b5a1b17d-55d1-4e20-a1fd-9f4a5aa2e460 61 fields · synced 22 Oct 2026
  • EUDAMED 08682190074812|B-08682190074812 61 fields · synced 19 May 2026