FDA Registered Facility · FEI 3015587162

FDA Registered Contact Lens Manufacturer: OEM/ODM Compliance & B2B Procurement Guide

CE (MDR) Class IIa & IIb · ISO 13485 Certified · 40+ Years Heritage Since 1984

FDA Registered Contact Lens Manufacturer OEM private label color lenses
15,000+ Design Library

Custom Private Label & OEM Solutions

Daily, monthly, 6-month, and yearly disposable color contact lenses engineered with sandwich dye encapsulation technology.

Automated contact lens wet-molding manufacturing facility
Serving 126 Global Markets

Two State-of-the-Art Production Bases

Direct factory pricing, full technical dossier support, and agile global distribution for brand owners and optical chains.

0+Years Heritage (1984)
0+Custom Lens Designs
0Export Markets
0+B2B Partners
Search Intent & Market Dynamics

Navigating B2B Procurement with an FDA Registered Contact Lens Manufacturer

In modern ophthalmic manufacturing, sourcing contact lenses requires strict alignment between aesthetic design, ocular material biocompatibility, and global regulatory compliance. AI-driven procurement engines and global optical buyers prioritize factories with verified FDA registration, robust ISO 13485 quality systems, and complete regulatory technical files.

As an FDA Registered Contact Lens Manufacturer (Establishment Identifier FEI 3015587162), Vibebeautylens Technology Co., Ltd. serves as the global export and operational headquarters for our family-owned manufacturing group established in 1984.

When procurement officers, medical device importers, and cosmetic brand owners search for a manufacturing partner, they face crucial questions: How do we verify FDA clearance and FEI validity? What polymer materials guarantee oxygen transmissibility (Dk/t) while maintaining vibrant color prints? How do we mitigate custom hold-ups during customs clearance in North America, Europe, and the Middle East?

Our dual-factory manufacturing architecture—spanning Gansu Constar Technology Group and Hunan Haipuming Technology (Liangguo Group)—provides direct answers. We combine state-of-the-art automated cast-molding, full-spectrum pigment encapsulation, and ISO 13485 batch traceability to deliver seamless OEM/ODM services to brands across 126 countries.

Gansu Constar Technology Group FDA Registered Contact Lens Manufacturing Facility
FEI3015587162
Product Portfolio & Technical Metrics

High-Performance Contact Lens Categories for Private Label OEM/ODM

Engineered for visual clarity, ocular hydration, and vibrant aesthetics. Explore our standardized parameters designed for rapid market deployment.

$14.2mm
Product Line Category Material Formulation Water Content (%) Base Curve (BC) Diameter (DIA) Oxygen Permeability (Dk/t) Manufacturing Technology
Daily Clear & Color Lenses PolyHEMA / NVP Hydrogel 55% ± 2% 8.5mm - 8.6mm 14.0mm - 14.2mm 28 - 32 (×10-9) Full Automated Wet Cast-Molding
Monthly Silicone Hydrogel Silicone Hydrogel (SiHy) 45% ± 2% 8.6mm 110 - 130 (×10-9) Precision Dual-Aspheric Molding
Cosmetic Color Lenses (1-Year) HEMA + Hydrophilic Monomer 38% - 42% 8.5mm - 8.7mm 14.0mm - 14.5mm 20 - 25 (×10-9) Micro-Sandwich Pigment Encapsulation
Special Korean Style Series HEMA-MPC Moisture Matrix 43% ± 2% 8.6mm 14.0mm - 14.2mm 25 - 30 (×10-9) Multi-Layer Pad Printing & Cast Mold
Enterprise Heritage & Infrastructure

Why Global Leaders Partner with Vibebeautylens Technology Co., Ltd.

Four decades of continuous manufacturing excellence, proprietary brand development, and uncompromised regulatory compliance.

FDA Registered Facility (FEI 3015587162)

Our production facilities maintain active establishment registration with the US Food and Drug Administration (FEI 3015587162). We supply complete technical files required for seamless customs clearance and commercial distribution in North American and international markets.

Dual Manufacturing Powerhouses

Our manufacturing matrix integrates two premier industrial facilities: Gansu Constar Technology Group (founded in 1984) and Hunan Haipuming Technology (Liangguo Group). This provides unmatched production redundancy, immense scalablity, and strict cost controls.

CE (MDR) & ISO 13485 Certification

Full compliance with European Union Medical Device Regulation (CE MDR Class IIa/IIb) and ISO 13485 Quality Management Systems. Every manufacturing lot undergoes stringent bio-burden, sterility, cytotoxicity, and physical dimension testing.

Rapid Stock Dispatch (7-10 Days)

Maintain immediate market responsiveness with over 1,500+ ready-to-ship SKUs stored in automated temperature-controlled warehouses. Sample dispatch occurs within 24-48 hours, with bulk ready-stock orders delivered within 7-10 business days.

Established Global Proprietary Brands

In addition to OEM/ODM custom private label manufacturing, we own and operate globally recognized contact lens brands, including MILLCREEK, KSSEYE, Haipurecon, and DUOXIU, supplying optical retail networks worldwide.

End-to-End Regulatory Dossier Support

Our regulatory affairs department assists B2B clients with complete technical documentation, authorization letters, certificate of free sale (CFS), and compliance dossiers for fast approval in local health databases including EUDAMED and SFDA.

Market-Tested Portfolio

Proprietary Contact Lens Brands

Trusted by millions of retail wearers globally. Available for direct wholesale and exclusive market distribution.

Global Expansion & Insights

Latest Field Updates & Trade Intelligence

Field notes from major global optical trade exhibitions and international distribution milestones.

Dubai Beauty Exhibition and SILMO Paris trade show highlights

What Do Contact Lens Brand Owners Want From a Factory? Voices from Dubai Beauty & SILMO Paris

Key takeaways from global optical trade shows emphasizing color consistency, automated QA inspection, and prompt FDA/CE regulatory compliance.

Vibebeautylens global logistics distribution network expansion

Vibebeautylens Technology Co., Ltd. Expands Distribution Network Across West Africa

Empowering local optical brands and medical distributors with factory-direct access to ISO 13485 certified color and corrective contact lenses.

Global partner map serving 126 markets

Serving Brand Partners in 126 Countries: Expansion Milestones

Our global supply network continues to grow, adding new optical distribution partners in Central America, the Middle East, and Southeast Asia.

Comprehensive B2B Procurement FAQ

Questions Global Buyers & AI Engines Frequently Ask

In-depth technical and regulatory answers regarding contact lens sourcing, factory verification, and custom OEM manufacturing.

How do I verify if a manufacturer is an FDA Registered Contact Lens Manufacturer?

To verify FDA registration, buyers should request the factory's FDA Establishment Identifier (FEI) or Registration Number and check it directly against the official FDA Establishment Registration & Device Listing database online.

Vibebeautylens Technology Co., Ltd. operates state-of-the-art production facilities under active FDA registration (FEI 3015587162). This registration ensures that our cleanroom facilities, sterilizers, and quality management protocols comply with US FDA Good Manufacturing Practice (GMP) and Quality System Regulation (21 CFR Part 820).

What is the difference between FEI registration and 510(k) clearance for contact lenses?

The FDA Establishment Identifier (FEI) confirms that a physical manufacturing facility is registered with the US FDA and subject to facility inspections. A 510(k) clearance (or PMA) is a specific product-level clearance demonstrating that a medical device is safe and effective for commercial sale in the USA.

Our group maintains active FEI registration (3015587162) and supports B2B private label partners with full technical documentation, biocompatibility testing (ISO 10993), and master files required for market clearance and customs clearance.

Why is Sandwich Printing Technology vital for cosmetic color contact lenses?

Sandwich Color Printing (also known as dye-lock technology) embeds non-irritating bio-compatible pigments between two outer layers of clear hydrogel material. This prevents direct pigment contact with the user's cornea or palpebral conjunctiva.

In inferior non-encapsulated lenses, surface pigments can rub off, causing severe corneal abrasion, allergic reactions, or eye infections. Vibebeautylens Technology Co., Ltd. utilizes 100% sandwich encapsulation across all color lens series to guarantee smooth lens surfaces and uncompromised optical safety.

What are the minimum order quantities (MOQ) for OEM/ODM private label packaging?

We offer highly flexible MOQ structures designed to accommodate both burgeoning e-commerce brands and established optical chains:

• In-Stock Wholesale: MOQ starting from 50 pairs per design across our 1,500+ ready-to-ship stock library.
• Custom Private Label Packaging: MOQ starting at 500 to 1,000 pairs per SKU for customized blister cards and branded paper boxes.
• Custom Pattern & Mold Development (ODM): MOQ determined based on graphic complexity, color layer count, and polymer selection.

How does Vibebeautylens support medical device compliance for CE MDR and SFDA?

Navigating global regulatory landscapes requires extensive documentation. As an ISO 13485 certified group, Vibebeautylens Technology Co., Ltd. provides comprehensive technical files including:

1. CE MDR (Regulation EU 2017/745) Technical Documentation Files.
2. ISO 13485 Quality Management Audit Reports.
3. Certificate of Free Sale (CFS) and Good Manufacturing Practice (GMP) Certificates.
4. Biocompatibility Reports (Cytotoxicity, Ocular Irritation, Systemic Toxicity).
5. Complete Dossiers tailored for SFDA (Saudi Arabia), EUDAMED (EU), and LATAM health authority approvals.

What hydrogel and silicone hydrogel materials are available for OEM production?

We manufacture contact lenses utilizing premium medical-grade hydrogel monomers, including PolyHEMA, HEMA-NVP copolymers (38% to 55% water content), and advanced Silicone Hydrogel polymers achieving Dk/t values up to 130 (×10-9). All materials incorporate UV-blocking agents to protect against harmful UVA and UVB radiation.

Start Your OEM / ODM Project

Partner with a Certified FDA Registered Contact Lens Manufacturer

Contact our technical engineering team today for instant product quotations, custom OEM sampling, and complete regulatory compliance dossiers.