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Hyasem

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

Active European Union

Ref AG007, AG112, AG008

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682190076373 Basic UDI-DIDate30 Apr 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Device Name
HYASEM Intra-articular Gel
HYASEM Intra-articular Crosslinked Gel
Model / Reference
AG007, AG112, AG008
Primary DI / UDI-DI
08682190076373, 08682190076489, 08682190076380, 08684771340897, 08684771340903, 08684771340880
Basic UDI-DI
B-08682190076373, B-08682190076489, B-08682190076380, B-08684771340897, B-08684771340903, B-08684771340880
EMDN Code
P900402 Resorbable filling and reconstruction devices
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

  • 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