CE Certified Contact Lens ODM China Exporter & Exporters

All exported medical and cosmetic contact lenses are produced in accordance with ISO 13485:2016 Quality Management Systems for Medical Devices. Export batches are accompanied by valid CE certificates issued by notified bodies, Certificates of Analysis (COA) specifying base curve, diameter, center thickness, and water content, as well as comprehensive ISO 10993 cytotoxicity, ocular irritation, and systemic toxicity testing documentation.

Our manufacturing facility strictly implements a patented cast-mold sandwich encapsulation technique. Color pigments derived from pharmaceutical-grade iron oxides and titanium dioxides are sealed between inner and outer layers of uncolored optical hydrogel polymer. The color layer never makes direct contact with the conjunctiva or cornea, preventing irritation, surface roughing, and dye leaching under standard wear and enzymatic cleaning cycles.

For standard catalog designs using existing color tooling and in-stock diopters, MOQs start as low as 50 to 100 pairs for market testing. For fully customized private label programs—including bespoke outer paper packaging boxes, custom blister foil stamping, and localized instruction leaflets—MOQs typically range from 500 to 1,000 units per artwork SKU, supported by our turnkey packaging design and prepress engineering teams.

Yes. Our casting molds accommodate both 0.00 Plano fashion lenses and 24 corrective diopter steps ranging from -1.00 to -8.00. We utilize high-speed automated laser power meters to verify vertex power and axis consistency on every production run, ensuring equal optical precision for both daily disposable and annual wear product tiers.

Prior to release, each production lot undergoes bioburden evaluation, sterility assurance validation (SAL 10⁻⁶ via autoclave moist-heat cycles), visual optical projection inspection for edge nicks or tears, blister seal integrity vacuum bubble leak tests, and aging stability studies under accelerated temperature conditions to verify stated 3 to 5 year shelf-life validity.