CE Certified Contact Lens Wholesale Supplier Manufacturer & Wholesalers

Eyebeauty provides an end-to-end CE MDR (Regulation EU 2017/745) Class IIa Technical Documentation dossier. This includes Notified Body-issued CE Certificates, the official Declaration of Conformity (DoC), ISO 13485:2016 Quality Management certificates, Clinical Evaluation Reports (CER) per MEDDEV 2.7/1 rev. 4, ISO 10993 full biocompatibility profiles (cytotoxicity, delayed hypersensitivity, systemic toxicity, ocular irritation), and validation files for terminal moist heat steam autoclave sterilization (ISO 17665).

We utilize a proprietary, fully automated cast-molding sandwich technology (Micro-encapsulated Color Lock). Unlike budget producers who apply color via pad-printing directly onto finished lenses, our process encapsulates FDA-approved, medical-grade color pigments entirely within the optical hydrogel monomer matrix. The color pigment layer is sealed internally between two distinct protective transparent layers, preventing any contact with corneal or conjunctival tissue.

Yes. We regularly supply Korean optical chains and US brand incubators with customized technical dossiers. For South Korea, we provide the requisite manufacturer-side files (Plant Master Files, stability testing, sterilization validation, raw material monomer certificates) needed by your licensed Korean importer to secure MFDS medical device item approval. For North America, our manufacturing plant holds an active US FDA Registration (FEI: 3015587162) to streamline 510(k) equivalency reviews.

For our ready-to-ship house brands (MILLCREEK, KSSEYE, Haipurecon, DUOXIU), minimum orders start from just 50 to 100 pairs per SKU with an immediate dispatch window of 7–10 working days. For fully custom OEM/ODM private label programs (custom blister foil typography, serialized outer retail boxing, custom diopter curves, and proprietary chromatic designs), baseline minimums typically run between 500 to 1,000 pairs per color/power tier, with standard manufacturing lead times of 25–35 days following digital artwork sign-off.

Our high-precision automated mold tooling supports plano (0.00 diopter) cosmetic lenses as well as corrective powers spanning -0.50D to -6.00D in 0.25D increments, and -6.50D to -10.00D in 0.50D increments. Custom cylinder/axis toric molds for astigmatism correction and hyperopic (+0.50D to +6.00D) designs can be tailored for dedicated long-term OEM contracts.

Lenses are sealed in heavy-duty medical-grade polypropylene (PP) blister packs containing isotonic buffered saline solution, capped with five-layer composite aluminum barrier foils hermetically heat-sealed to prevent evaporation and microbial ingress. Glass vial options (medical-grade Type I neutral borosilicate glass with tear-off aluminum-plastic flip caps) are also available. Secondary and tertiary master cartons are engineered with 5-ply reinforced corrugated cardboard and moisture-barrier shrink films.

Our quality control protocols comply strictly with ISO 18369 (Ophthalmic optics – Contact lenses). Every production lot undergoes automated computerized imaging inspection to detect edge defects, micro-tears, or eccentric pigment distribution. Subsequent lot release testing includes water content verification (refractometry), center thickness verification, base curve radius determination (interferometry), edge contour analysis, oxygen permeability (polarographic Dk measurement), and post-autoclave sterility validation (USP <71> / Ph. Eur. 2.6.1).