Vionell Intim-HydroGel

Device Name

Vionell Hydrogel

Model / Reference

RD-005116

Primary DI / UDI-DI

10011509031782

Basic UDI-DI

B-10011509031782

EMDN Code

U0803 Vaginal devices in the form of solutions/creams/ova/tablets

Device Class

Class IIa

Market of Registration

Germany

EUDAMED SRN

US-MF-000024551

Authorised representative

COMBE EUROPA S.L ES-AR-000023377

• Algasiv

  Class I

  CE/MDR

• Vagisil RD5033

  Class II

  GUDID on market

• Vagisil Gel Lubrificante Vaginale

  Class IIa

  CE/MDD

• Internal Hydrating Gel

  Class II

  FDA 510(k) K141718 Active Cleared 13 Nov 2014

• External Moisturizing Gel

  Class II

  FDA 510(k) K171855 Active Cleared 21 Jul 2017

• Vaginal Moisturizing Gel

  Class II

  FDA 510(k) K150615 Active Cleared 1 May 2015

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