This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


DEVICE DETAILS

NAME OF DEVICESOFT CONTACT LENS
ESTABLISHMENT NAMESOLAVISH SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB4596723-139096
BRAND NAMEIVY LENSE
MEDICAL DEVICE CATEGORYMD 0105 - Non-active ophthalmologic devices
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONSoft Contact Lens is a coloured contact lens with 57 varieties of colours intended for cosmetic purpose to enhance and change the hue of eyes of the wearer. It is meant for short-term contact and reusable. Soft Contact Lens is indicated for adults for cosmetic effects. Soft Contact Lens comes in package containing preservation solutions of boric acid and sodium chloride salt solutions. Soft Contact Lents is a sterile product. The lens is designed to be attached to the corneal tear layer and the lens is slightly covered by the eyelid. When blinking, the eyelid slides on the surface of the lens, causing the lens to move slightly. The tears provide the necessary lubrication for the cornea and help to expel foreign matter.
DEVICE INTENDED PURPOSEIntended for cosmetic purpose to enhanced and change the hue of the eyes of the wearer.
VALIDITY DATE OF REGISTRATION08/07/2023 - 07/07/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Ivy LenseME28
2Ivy LenseME29
3Ivy LenseME30
4Ivy LenseME54
5Ivy LenseP01
6Ivy LenseP02
7Ivy LenseP03
8Ivy LenseP05
9Ivy LenseFA12-1
10Ivy LenseFA12-2
11Ivy LenseZ6
12Ivy LenseZ7