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Hyalexo Mono

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

Ref AG008

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08684771349999 Basic UDI-DI Date25 Aug 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
HYALEXO MONO Intra-articular Gel
Model / Reference
AG008
Primary DI / UDI-DI
08684771349999, 08684771349982, 08684771349890
Basic UDI-DI
B-08684771349999, B-08684771349982, B-08684771349890
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU 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