EpiGARD

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Device Name

EpiGARD 8x10

Model / Reference

WV3201

Primary DI / UDI-DI

04260310342016

Basic UDI-DI

B-04260310342016

EMDN Code

M04040602 Polyurethane dressings, combined with other substances

Device Class

Class IIb

Market of Registration

Germany

EUDAMED SRN

DE-MF-000007828

• EpiGARD

  Class IIb

  CE/MDD

• Modification to Visitome 20-10 Microkeratome

  Class I

  FDA 510(k) K042083 Active Cleared 16 Nov 2004

• Leadfix Bioresorbable Membrance Pin System

  Class II

  FDA 510(k) K974392 Active Cleared 30 Jan 1998

• Vistitome 20-10 Microkeratome

  Class I

  FDA 510(k) K014000 Active Cleared 11 Mar 2002

• Diamond Nd:yag Ophthalmic Laser

  Class II

  FDA 510(k) K901636 Active Cleared 22 Jun 1990

• Crystal Focus Emerald Laser Slt Mcx 1.5 Convex Pro

  Class II

  FDA 510(k) K910027 Active Cleared 25 Sep 1991

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