WHO ARE WE
Horien Optic (Malaysia) Sdn Bhd is a Malaysia-based company with its primary business is to import and distribution of contact lenses and lens care products under the brand named Eye Secret, which is manufactured by Yung Sheng Optical Co. Ltd. in Taiwan.
OUR MANUFACTURER
Yung Sheng Optical Co., Ltd. was found in 2011. Major business is manufacturing and sales of soft contact lens and lens care product. With its innovative R&D team, advanced manufacturing facilities and professional marketing and sales group, Yung Sheng has received the following: ISO 9001:2008 and ISO 13485:2003 certifications, Japan’s FMA (Foreign Manufacturer Accreditation), European CE and Taiwan GMP (Good Manufacturing Practice) aiding expansion in our global market.
QMS CERTIFICATES
YUNG SHENG has acquired a variety of certificates and is always trying to be in compliance with world’s standards and regulations.
ISO 9001
ISO 1345
TAIWAN FDA GMP
JAPAN MHLW
KOREA GMP
PRODUCT LICENSE - U.S FDA / CE
USA : FDA secured
- Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for 1 Day 510(K) Number: K143190
- Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily wear 510(K) Number: K150630
- Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact Lens 510(k) Number: K151586
- Eye Secret 38 UV Aspheric Color (Polymacon) Soft (Hydrophilic) Contact Lens For Daily/1-Day 510(k) Number: K143052
Europe CE(93/94/EEC)
FDA 510(K) K132854-38% Clear Lens-02
PRODUCT LICENSE - JAPAN
1Day Clear Lens UV
Number: 22700BZX00328000
1Day Color Lens UV
Number: 22700BZX00327000
Monthly Clear &Color Lens UV Number:
22700BZX00345000
AUTHORIZED CERTIFICATES IN MALAYSIA
Our company compliance with Malaysia Standard by obtaining certificates from
- Good Distribution Practice for Medical Device (GDPMD).
- Warehouse storage system
- Products quality
- Warehouse cleanliness & etc.
- Medical Device Authorities for all existing selling products (including color lenses and solution)
- Establishment Licence as Authorized Representative for from MDA.
Authorized Certificates in Malaysia
Authorized Certificates in Malaysia
