Contact lens

Device Name

Contact lens

Model / Reference

42% Hefilcon A, ZD39Z0

Primary DI / UDI-DI

471987515ZD39Z0LU

Basic UDI-DI

47198751542HKB

EMDN Code

Q021004010101 Contact lenses - hydrogel, daily single-use

Device Class

Class IIa

Special Device Type

Standard soft contact lenses

EUDAMED SRN

TW-MF-000008432

Authorised representative

Emergo Europe B.V. NL-AR-000000116

• Contact lens

  Class IIa

  CE/MDR

• Saview 55F (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear

  Class II

  FDA 510(k) K020917 Active Cleared 6 May 2002

• Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

  Class II

  FDA 510(k) K240477 Active Cleared 1 Jul 2024

• Saview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear

  Class II

  FDA 510(k) K092852 Active Cleared 11 Mar 2010

• Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 58 UV Toric (Etafilcon a)

  Class II

  FDA 510(k) K132146 Active Cleared 30 Aug 2013

• Saview-Colors 42 UV (Hefilcon a), Toric (Hefilcon a), Multifocal (Hefilcon a)Soft (Hydrophilic) Contact Lens

  Class II

  FDA 510(k) K123484 Active Cleared 29 Mar 2013

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