Certification
Quality & Certifications
At iQueye, we take eye safety seriously. Our contact lenses are manufactured by a certified facility that meets international quality and safety standards. Below are the certifications that back every pair of lenses we sell.
EC Certificate — EU Medical Device Directive
Our lenses are manufactured in compliance with Council Directive 93/42/EEC on Medical Devices, as assessed and certified by DNV Product Assurance AS — an EU-recognized Notified Body (NB 2460).
This EC Certificate covers the full quality assurance system for the design, production, and final inspection/testing of soft contact lenses, in accordance with Annex II of the EU Medical Device Directive.
- Certificate No.: 1000029613-PA-NA-CHN
- Issued by: DNV Product Assurance AS, Norway
- Notified Body: 2460
- Standard: Council Directive 93/42/EEC
- Product covered: Soft Contact Lens
- Manufacturer: Jilin Realcon Contact Lens Co., Ltd
- Valid until: December 31, 2028
ISO 13485 — Medical Device Quality Management System
Our manufacturing partner holds ISO 13485:2016 certification — the internationally recognized standard for quality management systems in the medical device industry. This certification is required by regulatory authorities across the EU, UK, Canada, Japan, Australia, and many other markets.
ISO 13485 ensures that every stage of production — from design and raw materials to final product testing — follows documented, audited, and continuously improved quality processes.
- Standard: ISO 13485:2016
- Issued by: DNV
- Manufacturer: Jilin Realcon Contact Lens Co., Ltd
- Valid until: 2027
About Our Manufacturing Partner
iQueye lenses are manufactured by Jilin Realcon Contact Lens Co., Ltd, located in Jilin City, Jilin Province, China. Jilin Realcon is a dedicated soft contact lens manufacturer with over a decade of production experience, supplying lenses to markets across Europe, Asia, and North America.
All certifications listed on this page are held by Jilin Realcon Contact Lens Co., Ltd as the product manufacturer.