CE Certified & ISO 13485 Compliant

CE Certified ODM Contact Lenses Factory & Supplier

Industrial-Grade Private Label Manufacturing, Advanced Hydrogel & Silicone Optical Engineering, and Rapid B2B Global Distribution

Factory Direct Catalog

High-Demand Wholesale Contact Lens Portfolio

Turnkey OEM & ODM optical SKUs engineered for maximum biocompatibility, high visual clarity, and high-margin B2B resale.

Cosplay / Anime EYESHARE Cosplay Contact Lenses Anime Soft Hardness Crazy Design Sharingan

EYESHARE Cosplay Anime Soft Contact Lenses Crazy Design Sharingan Eye Lens

Ultra-vivid opaque pigmentation with 38% water content polymer matrix. Optimized for costume and pop-culture retail channels.

Beauty / Natural Haipurecon Siri 2.0 Series Soft Contact Lenses Beautiful Big Eyes Makeup

Haipurecon Siri 2.0 Series Soft Contact Lenses Big Eyes Makeup Wholesale

Multi-tone limbal ring architecture designed for subtle depth and natural enlargement effect. Perfect for cosmetic lines.

Hot Promotion Freshgo Colored Contact Lenses Blended Eye Color Contact Lens

Freshgo Colored Contact Lenses Blended Eye Color High-Margin Series

Precision blended gradient matrix suitable for dark iris coverage. Cost-effective B2B volume wholesale solutions.

Silicone Hydrogel Medical Prescription Fashion Luxury Soft Eye Contact Silicone Hydrogel

Medical Prescription Silicone Hydrogel Colored Contact Lens (40% Water)

High oxygen transmissibility (Dk/t) silicone hydrogel formulation with corrective diopter options (-0.50 to -8.00D).

Yearly Wear Haipurecon Taylor and Pola Series Yearly Color Contact Lenses

Haipurecon Taylor & Pola Series Yearly Color Soft Contact Lenses OEM/ODM

Durable poly-HEMA formulation engineered for extended comfort and tear-film stability across annual replacement cycles.

Daily Disposable Direct Factory Sales Natural Daily Elegant Lenses Eye Pupilentes

Direct Factory Natural Daily Elegant Eye Pupilentes Soft Contact Lenses

Ultra-thin edge profile designed for single-use daily convenience. Sterile blister strip packaging ready for private branding.

Packaging & Merch Best Seller Packaging Eyewear Display Estuches Eye Glass Accessories

Custom Contact Lenses Retail Packaging & Eyewear Accessory Kits

Turnkey retail presentation cases, luxury metallic compact boxes, and custom branded optical store merchandise display solutions.

Travel Care Kits 5 Sets Wholesale Colorful Conjoined Body Contact Lens Travel Kit Applicator

5-Set Wholesale Colorful Conjoined Body Contact Lens Travel Applicator Kits

Medical-grade silicone insertion wands, micro-tweezers, and anti-leak solution containers designed for high add-on order value.

50M+
Annual Unit Output
ISO 13485
Medical Device Standard
CE 2195
Certified European Compliance
< 20 Days
Custom OEM Lead Time
Technical Whitepaper

Navigating European Regulatory Compliance & Precision Bio-Optical Engineering

An authoritative insight for B2B brand owners, pharmaceutical buyers, optical retail chains, and international distributors.

In the rapidly evolving global ophthalmic market, procuring contact lenses requires more than competitive pricing; it demands absolute regulatory security, biophysical consistency, and advanced material science. As a specialized CE Certified ODM Contact Lenses Factory & Supplier, Stephies Lens CO., LTD operates at the intersection of medical compliance, optical hydrogel chemistry, and automated manufacturing technology.

Contact lenses are categorized as Class IIa or Class IIb medical devices under strict regulatory frameworks worldwide, including the European Union Medical Device Regulation (EU MDR 2017/745) and US FDA 510(k) standards. Establishing an OEM/ODM partnership with a fully audit-ready manufacturing facility eliminates regulatory friction, protects brand equity, and guarantees that end consumers receive biocompatible products that preserve corneal integrity and ocular health.

The Technical Imperative of CE Certification & ISO 13485:2016 Systems

Achieving official CE compliance is an exhaustive multi-stage validation process. Our factory operates under cleanroom environments certified to ISO 14644-1 Class 8 cleanliness, utilizing automated optical molding lines and micro-filtered purifications. Every manufacturing batch undergoes rigorous biophysical testing, including:

  • Cytotoxicity & Biocompatibility Screening: Ensuring zero cell toxicity according to ISO 10993 standards.
  • Spectral Transmittance Verification: Validating clear optical pupil zones to prevent visual distortion or peripheral obstruction.
  • Oxygen Transmissibility (Dk/t) Profiling: Guaranteeing adequate corneal oxygen flux to prevent corneal hypoxia and ocular edema.
  • Sterilization Assurance Levels (SAL 10⁻⁶): Moist heat steam autoclave sterilization validated under ISO 17665.
R&D Innovation

Key Technological Trends Driving Contact Lens Innovation

How next-generation polymer chemistry and precision micro-tinting are defining the future of cosmetic and corrective eyewear.

Silicone Hydrogel (SiHy) Matrix Advancement

Traditional hydrogel (poly-HEMA) is giving way to advanced Silicone Hydrogel formulations. By incorporating siloxane monomer chains into the polymer matrix, oxygen permeability (Dk/t) increases up to 4x compared to conventional soft lenses. This permits extended daily wear comfort, reduced corneal redness, and superior lipid resistance.

3D Sand-Layer Pigment Encapsulation

Safety in color contact lens manufacturing requires zero direct contact between inorganic color pigments and the delicate corneal epithelium. Our ODM facility utilizes proprietary 3D Sandwich Printing Tech, locking bio-safe color pigments inside two transparent micro-layers of polymer, eliminating color fading and surface friction entirely.

Hyaluronic Acid Micro-Fluidic Moisture Lock

To combat digital eye strain and dry-eye symptoms caused by prolonged screen time, modern contact lens formulations integrate hydrophilic moisturizing agents such as Sodium Hyaluronate (HA) and Polyvinylpyrrolidone (PVP) directly into the lens packaging saline solution, retaining surface hydration over 16 continuous hours.

Global Supply Chain Intelligence

Future Procurement Trends in the B2B Optical Industry

Strategic shift toward agile manufacturing, eco-conscious packaging, and hyper-customized private label branding.

1. Low Minimum Order Quantities (MOQ) for Rapid Market Validation

Emerging indie beauty brands and regional e-commerce retailers can no longer afford massive upfront inventory capital. Future procurement favors ODM suppliers offering flexible, low-MOQ trial orders. Our factory supports mixed-color SKUs, enabling brands to test localized consumer color preferences before scaling to high-volume container shipments.

2. Sustainable & Recyclable Blister Packaging Protocols

Environmental regulations across Europe and North America are mandating reduced plastic waste in single-use medical consumables. Sourcing strategies are prioritizing factories that utilize polypropylene (PP) blister cups with aluminum foil seals that allow complete material separation and 100% recyclability without compromising sterile container seal integrity.

3. Turnkey OEM Private Labeling & Bespoke Packaging

B2B buyers increasingly expect full-service ODM integration. Modern manufacturers must not only supply high-grade lenses, but also deliver fully finished retail products—complete with custom outer box design, barcode generation, multi-language compliance labeling, IFUs (Instructions for Use), and localized user guides.

4. Strict Regulatory Traceability & Digital Quality Audits

With global customs enforcement heightening scrutiny on optical devices, procurement officers require real-time access to batch Certificate of Analysis (CoA), sterilization reports, and raw material safety data sheets (MSDS). Working with a CE and ISO certified supplier ensures hassle-free import clearance across all major ports.

Technical Specifications

Comprehensive Optical Matrix & Category Benchmarks

Standard parameters for custom OEM order configurations and private label product line structuring.

Category Diameter (DIA) Base Curve (BC) Water Content Material Tech Diopter Range (Power) Ideal Channel
Natural Beauty Lenses 14.0 mm - 14.5 mm 8.5 mm - 8.6 mm 38% - 42% Poly-HEMA / Sandwich Tint Plano 0.00 to -8.00D Cosmetic Retail, E-Commerce
Silicone Hydrogel Rx 14.0 mm - 14.2 mm 8.4 mm - 8.6 mm 40% - 45% SiHy High Oxygen Matrix -0.50D to -10.00D Optical Chains, Clinics
Cosplay & FX Series 14.2 mm - 14.5 mm 8.6 mm 38% - 40% Opaque Layer Encapsulation Plano (0.00) / Custom Rx Costume Shops, Pop Culture
17mm Mini Sclera 17.0 mm 8.8 mm - 9.0 mm 40% Wide Iris Molded Polymer Plano (0.00) Stage Makeup, SFX Retail
22mm Full Sclera 22.0 mm 11.0 mm (Full Eye) 38% Lathe-Cut Medical Grade HEMA Plano (0.00) Film, TV, Professional FX
Lens Care & Solutions 10ml - 360ml N/A Saline Base HA Rewetting / Multi-Purpose N/A Add-On Retail Accessories
Why Partner With Us

Enterprise Capabilities of Stephies Lens CO., LTD

Integrating end-to-end industrial optical manufacturing with white-glove B2B client support.

Fully Stocked Catalog for 7-Day Shipping

We maintain a massive ready-to-ship inventory across hundreds of natural, cosplay, and optical lens styles. In-stock wholesale orders are quality inspected and dispatched within 7 business days, providing clients with unparalleled inventory turnover speed.

Bespoke ODM Engineering & Custom Iris Patterns

Want an exclusive lens line that competitors cannot duplicate? Our in-house optical design specialists craft bespoke iris vector patterns, customized limbal rings, and specific color gradients from scratch, backed by rapid 3D prototyping and sample validation.

Global Door-to-Door Logistics & Customs Clearance

We take the complexity out of international medical device transport. Our export division manages complete documentation, custom clearance brokerage, and direct door-to-door express delivery (DHL, FedEx, UPS) or sea/air freight forwarding across 85+ countries.

Buyer FAQ

Frequently Asked B2B Sourcing Questions

Clear, direct answers regarding certifications, OEM branding, lead times, and sample evaluations.

What specific CE and quality certifications does your factory hold for contact lens production?

Our manufacturing facilities operate under strict ISO 13485:2016 Medical Device Quality Management Systems. Our products carry official European CE certification (CE 2195 under Class IIa medical device directives), ensuring full legal compliance for import, distribution, and retail sales across the EU and accepting international territories.

Do you accept small trial order quantities for new brand launches?

Yes! We actively support emerging brands and retail startups through our SMB Growth Program. We allow flexible, low MOQ trial orders with mixed colors and power ranges across our catalog, allowing you to test market demand prior to placing large production runs.

What is the standard lead time for custom private label (OEM) orders?

For in-stock catalog products ordered under standard packaging, dispatch occurs within 7 days. For custom OEM private label orders—which include customized blister foil printing, branded outer box packaging, and multi-language instructions—the lead time is typically 20 calendar days after artwork finalization.

Can I request physical samples for optical quality and color evaluation before placing a bulk order?

Absolutely. We maintain ready stock of all catalog colors and prescription diopters. Sample kits can be prepared and dispatched via international express courier within 48 hours for your team to test material softness, lens edge comfort, color opacity, and packaging aesthetics.

What OEM private label customization options do you provide?

Our full turnkey OEM service covers custom-printed aluminum blister foils, glass vial branding, bespoke paper folding boxes, custom plastic lens storage cases, travel care kits, rewetting eye drop solutions, and branded instructions for use (IFU) leaflets matching your exact corporate visual identity.

What are the technical differences between 17mm Mini Sclera and 22mm Full Sclera lenses?

17mm Mini Sclera lenses cover the entire iris and extend partially onto the white sclera tissue, providing a dramatic enlargement effect while maintaining easy insertion and high wear comfort. 22mm Full Sclera lenses cover the entire visible eyeball for extreme theatrical, film, and SFX visual effects. Both use bio-compatible Poly-HEMA material engineered for short-duration occasion wear.

What payment methods and commercial credit terms do you support?

We support standard international B2B payment channels, including T/T (Telegraphic Transfer/Bank Wire), Letter of Credit (L/C), PayPal, Credit Card processing, Western Union, and MoneyGram. Flexible credit terms are available for repeat long-term wholesale distributors following initial credit assessment.

Start Your Private Label Contact Lens Project Today

Partner with an audit-ready, CE-certified ODM factory. Request our complete wholesale catalog, competitive pricing tiers, and OEM sample kits now.