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Konix Laparoscopic Lens Anti-Fog Solution and Sponge 6 Ml

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

Ref AFS-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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190864↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08698712455274 Basic UDI-DI 08698712455274UDI-DIDate23 Mar 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK190864 Date27 Aug 2020IssuedStatusActive

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 23 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  • Withdrawn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 Laparoscopic Lens Anti-Fog Solution and Sponge 6 Ml
Model / Reference
AFS-0001
Primary DI / UDI-DI
08698712455274
Basic UDI-DI
B-08698712455274
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIa
EU market of registration
Germany

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