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Konix Sterile Ultrasound Gel - 20 Ml

by Turkuaz Sağlik Hi̇zmetleri̇ Medi̇kal Temi̇zli̇k Ki̇myasal Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ 2 variants

Ref SUG-0001

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K101952↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08681715349695 Basic UDI-DI 08681715349695UDI-DIDate23 Feb 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK101952 Date27 May 2011IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Device Name
Konix Sterile Ultrasound Gel - 20 Ml
Model / Reference
SUG-0001
Primary DI / UDI-DI
08681715349695
Basic UDI-DI
B-08681715349695
EMDN Code
Z1399 Non-specific consumables for diagnostic instruments - other
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
TR-MF-000015402

Other devices from Turkuaz Sağlik Hi̇zmetleri̇ Medi̇kal Temi̇zli̇k Ki̇myasal Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Turkuaz Sağlik Hi̇zmetleri̇ Medi̇kal Temi̇zli̇k Ki̇myasal Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

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