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Eliteflex

by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi 5 variants

Ref EF-2-32Model ELITEFLEX - Sterile Sodium Hyaluronate Gel 2mL Prefilled Syringe (1,6%)

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-08699415733874 Basic UDI-DI 08699415733874UDI-DIDate30 May 2026RegisteredStatusActive

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  • Withdrawn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
ELITEFLEX - Sterile Sodium Hyaluronate Gel 2mL Prefilled Syringe (1,6%)
Model / Reference
ELITEFLEX - Sterile Sodium Hyaluronate Gel 2mL Prefilled Syringe (1, 6%), EF-2-32
Primary DI / UDI-DI
08699415733874
Basic UDI-DI
B-08699415733874
EMDN Code
A02010299 Infusion and irrigation syringes - other
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017811

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Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • 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