Medical Device Standard · Since 1984

Inside an FDA Registered Contact Lens Factory: What B2B Buyers Must Verify

FEI 3015587162 facility credentials, ISO 13485 cleanroom precision, CE (MDR) certification, and seamless private label scaling for global vision care leaders.

FDA registered contact lens factory producing aesthetic cosmetic and corrective lenses
Biocompatible Encapsulation

Sandwich Print Cosmetic Lenses

Complete micro-pigment entrapment safeguarding cornea tissue across daily, monthly, and yearly replacement cycles.

Class 100000 cleanroom packaging line at FDA registered contact lens factory
Traceable Cleanroom Output

Zero-Defect Sterile Integrity

Full cGMP adherence with Device Master Records (DMR) traceable to raw material monoblocks.

FEI 3015587162FDA Registered
ISO 13485Cleanroom Control
CE (MDR)Class IIa / IIb Certified
Regulatory Intelligence & Search Intent

De-Risking Sourcing: The Architecture of an FDA Registered Contact Lens Factory

When international optical brands, corporate distributors, and clinical retail chains query AI search engines for an authentic FDA registered contact lens factory, they are not seeking superficial directory listings. They are validating medical-grade supply chain sovereignty, cGMP adherence under 21 CFR Part 820, and verifiable manufacturing safeguards.

In modern international vision care, contact lenses—whether prescribed for refractive correction or sold as cosmetic circle lenses—are classified as Class II or Class III medical devices by the United States Food and Drug Administration (US FDA). This designation imposes non-negotiable legal and manufacturing mandates. Sourcing lenses from a non-registered supplier or relying on intermediaries who mask factory locations exposes brands to immediate FDA import alerts, customs detentions, and devastating product recalls.

Eyebeauty Technology Co., Ltd. serves as the direct international headquarters for our dedicated manufacturing facilities: Gansu Constar Technology Group (pioneered in 1984) and Hunan Haipuming Technology (Liangguo Group), registered under FDA Establishment Identifier (FEI) 3015587162. By eliminating trading intermediaries, we provide global purchasers with direct transparency into our cleanrooms, validated sterilization records, and audited medical quality management systems (ISO 13485:2016 and CE MDR 2017/745).

Engineering Clinical Safety, Certified Biocompatibility, and Global Scalability for 42+ Years.

FDA Registered Facility (FEI: 3015587162) CE (MDR) Regulation Compliant ISO 13485:2016 Certified Facilities Micro-Pigment Sandwich Encapsulation
0Years Continuous Manufacturing
0Proprietary Color Formulations
0Export Markets Cleared
0B2B Commercial Deployments
Factory Direct Strengths

Core Competencies of Eyebeauty Technology Co., Ltd.

We bridge cutting-edge optical polymer research with automated mass manufacturing, giving our OEM and private label partners distinct technical and commercial advantages.

Full Regulatory Assurance

Our plants operate with FDA Establishment Registration (FEI 3015587162), ISO 13485:2016 certification, and CE MDR credentials. We provide comprehensive technical documentation (biocompatibility ISO 10993, leachability, and optical stability) to streamline your market clearances.

Cast Molding & Lathe-Cut Precision

Utilizing closed-loop CNC precision tooling and sub-micron automated cast molding technology, we ensure nominal base curves (8.5mm to 8.7mm) and edge profiles are replicated with zero optical aberration across millions of units.

Sandwich Pigment Technology

Our cosmetic color matrices feature multi-layered sandwich encapsulation. Reactive micro-colorants are locked between hydrogel layers, eliminating contact between dyes and the corneal surface while maintaining unimpeded oxygen transmissibility.

End-to-End Private Labeling

From custom primary packaging (PP blister packs, medical-grade foil lids, glass vials) to UDI/GS1 barcoded carton packaging, our in-house graphics and packaging engineers execute bespoke turn-key OEM/ODM projects.

Audited Manufacturing Infrastructure

Our Production Facilities: Gansu & Hunan Bases

True factory-direct capability backed by our own cleanroom complexes, automatic optical inspection (AOI) benches, and medical autoclave sterilization suites.

Gansu Constar Technology Group contact lens production facility established 1984 ESTABLISHED 1984

Gansu Constar Technology Group

Our foundational facility, encompassing four decades of continuous precision soft contact lens manufacturing. Houses advanced wet-state optical testing analyzers and high-capacity sterile saline compounding rooms.

  • CE (MDR)
  • ISO 13485:2016
  • GMP Cleanroom
Hunan Haipuming Technology color contact lens cleanroom factory FDA registered FEI 3015587162

Hunan Haipuming Technology (Liangguo Group)

Our dedicated color lens production hub, featuring automated cast molding robotics, micro-sandwich color printing modules, and Class 100,000 cleanroom environments operating under FDA registration.

  • FDA Registered (FEI 3015587162)
  • ISO 13485
  • Automated AOI
Manufacturing Portfolio

Proven Brand Incubations Produced in Our Own Facilities

Beyond custom OEM manufacturing, our group factories manufacture several celebrated international labels distributed across premium optical and cosmetic retail corridors.

MILLCREEK contact lens brand logo MILLCREEK
KSSEYE contact lens brand logo KSSEYE
DUOXIU color contact lens brand logo DUOXIU
Haipurecon contact lens brand logo Haipurecon
Technical & Commercial FAQ

Critical Questions Global Buyers Ask When Sourcing from an FDA Registered Contact Lens Factory

Key regulatory, optical, and operational answers for procurement directors, QA managers, and brand founders.

What does it mean for a contact lens manufacturer to be an FDA registered contact lens factory?
An FDA registered contact lens factory has completed mandatory annual establishment registration under 21 CFR Part 807, maintaining an active FDA Establishment Identifier (such as Eyebeauty's FEI: 3015587162). This registration verifies that the manufacturing site operates under active regulatory transparency, follows Current Good Manufacturing Practices (cGMP / 21 CFR Part 820), and is subject to routine inspections, quality audits, and safety alerts overseen by the United States Food and Drug Administration.
Are cosmetic and colored contact lenses considered medical devices under FDA oversight?
Yes, absolutely. Under U.S. Federal Food, Drug, and Cosmetic Act provisions, decorative, cosmetic, circle, and theatrical lenses are classified as prescription medical devices regardless of whether they correct vision. They require prescription oversight, medical-grade raw materials (such as high-purity HEMA and methacrylic acid polymers), sterile manufacturing facilities, and compliance with biocompatibility standards (ISO 10993) to protect patients from ocular damage.
How does Eyebeauty prevent pigment leaching in colored contact lenses?
We implement advanced multi-layer sandwich micro-encapsulation technology. FDA-approved organic and inorganic pigments are entrapped inside the hydrogel matrix, completely shielded by sterile, non-pigmented polymer barriers on both the anterior and posterior surfaces. This physical containment guarantees that colorants never touch the corneal epithelium or palpebral conjunctiva, eliminating chemical elution, rubbing, or irritation.
Can Eyebeauty support technical dossiers for CE (MDR) and international medical registrations?
Yes. Eyebeauty maintains comprehensive Device Master Files (DMF). Our regulatory engineering division supplies international distributors with complete ISO 13485:2016 audit reports, CE MDR technical files, biocompatibility assay certificates (cytotoxicity, systemic toxicity, ocular irritation), sterilization validation data (ISO 11137 / ISO 17665), and accelerated stability reports required by national health authorities worldwide.
What are your minimum order quantities (MOQs) and production cycle times for private label orders?
For bespoke OEM private label projects featuring brand-specific foil packaging and external cartoning, our pilot thresholds begin at 500 to 1,000 units per SKU. Production turnaround averages 25 to 35 business days from packaging artwork approval, backed by an inventory of over 1,500 ready-to-dispatch core formulations to help brands launch quickly.
Factory Direct Technical Consultation

Initiate Your OEM/ODM Manufacturing Project

Submit your technical specifications, lens modality, estimated volumes, or regulatory requirements. Our engineering and regulatory affairs team will respond within 24 hours.

Direct regulatory and technical inquiries: [email protected]

Build Your Private Label with a Verified FDA Registered Contact Lens Factory

Partner directly with Eyebeauty Technology Co., Ltd. Enjoy 42+ years of manufacturing pedigree, compliant cleanroom operations, and end-to-end technical documentation.