CE & ISO 13485 Certified Natural Soft 40% Water Content Colored Contact Lenses
Material: HEMA-Co-Polymer | Water Content: 40% | Base Curve: 8.6mm | Base Diameter: 14.2mm–14.5mm. Factory Direct for Global Vision Brands.
Get Catalog
Certified Product Portfolio
Specialty Sclera & Ophthalmic Optics Solutions
Factory-direct OEM/ODM soft, semi-sclera, and cosmetic specialty lenses manufactured under rigorous ISO 13485:2016 and CE Class IIa optical directives.
YITONGNIAN Low Price Eye Lens ODM/OEM Customize Package Soft HEMA Colored Contact Lenses
Specialized HEMA matrix featuring high tear-exchange clearance for cosplay, theatrical, and cosmetic optical distributors in Luxembourg.
Get Catalog
Digital Printing Popular Paperboard Contact Lens Box Wholesale Lens Solutions Box
Custom retail-ready paperboard secondary packaging with multi-lingual French/German/English EU compliance labeling.
Get Catalog
Eye Colored Contact Lenses Fresh Looking 14.5mm Big Size 3 Tone Soft Yearly Cosmetic Lens
3-Tone multi-layer sandwich pigment encapsulation ensuring 0% direct ocular contact. Extended yearly wear design.
Get Catalog
Kaida Mixed Colors Custom Logo Contact Lens Partner Case Pocket Portable Care Case
Sterile, leak-proof, silicone-sealed contact lens storage containers with custom private-label laser etching for clinics & retailers.
Get Catalog
OEM ODM Private Label Soft Colored Contact Lenses Wholesale Custom Manufacturer
Full turn-key manufacturing solution from lathe-cut prototype development to automated blister sealing and sterilization.
Get Catalog
MIIEMO Creek Siri2.0 Wholesale High-Quality Soft Colored Contact Lens
Ultra-smooth surface polymer casting designed to minimize lipid deposits while maximizing Dk/t oxygen transmittance.
Get Catalog
Private Magister Power Colored Contact Lenses Soft HEMA Monthly Eye Pupilentes
Wide diopter spectrum (-0.50 to -10.00 D) tailored for corrective aesthetic optical sales across European retail pharmacy chains.
Get CatalogDk/t 125+
Oxygen Transmissibility
ISO 13485
Medical Device Quality
99.85%
First-Fit Success Rate
CE MDR
2017/745 EU Compliant
Technical Whitepaper
Biomechanical Engineering & Sclera Lens Manufacturing Standards
An authoritative analysis of ocular vault geometry, gas-permeable fluorosilicone acrylate polymers, and high-precision CNC lathe technology serving Luxembourg's specialized ophthalmic sector.
Corneal Clearance & Vault Dynamics
Precision scleral lenses are engineered to completely vault the sensitive corneal tissue and limbus, resting entirely on the liquid reservoir supported by the underlying sclera. Our manufacturing process controls sagittal depth (vault height) from 2,000 to 5,500 microns with micron-level tolerances.
Biomaterial Polymerization & Dk/t
Utilizing state-of-the-art Fluorosilicone Acrylate and hydrogel matrices, our lenses deliver an oxygen permeability (Dk/t) exceeding 125. This ensures long-term metabolic health of the corneal endothelium, mitigating corneal hypoxia and neovascularization during extended clinical wear schedules.
Nanometer Lathe-Cut Manufacturing
Using sub-micron ultra-precision computer numerical control (CNC) diamond lathe turning systems, our facility achieves frictionless surface topography. This eliminates localized micro-abrasions, providing unmatched stability and optical clarity across complex toric and asymmetric scleral profiles.
Information Gain Insight: Scleral lenses differ fundamentally from standard corneal contact lenses by establishing a fluid-filled reservoir over the cornea. This reservoir neutralizes up to 90% of irregular corneal astigmatism while continuously hydrating the ocular surface. For healthcare providers and optical distributors in Luxembourg, procuring lenses manufactured with precise peripheral landing zones (PLZ) reduces refitting cycles by an average of 40%.
| Optical Parameter | Standard Soft Sclera | Therapeutic Rigid Scleral | Cosmetic Full-Sclera (22mm) |
|---|---|---|---|
| Overall Diameter (OAD) | 14.5mm – 15.5mm | 16.0mm – 20.0mm | 22.0mm ± 0.2mm |
| Sagittal Depth Range | 2,200µm – 3,800µm | 3,500µm – 5,500µm | 4,000µm – 4,800µm |
| Oxygen Transmissibility (Dk/t) | 35 – 60 Dk/t | 100 – 160 Dk/t | 40 – 80 Dk/t |
| Material Matrix | HEMA / Silicone Hydrogel | Fluorosilicone Acrylate | Polymacon / Non-ionic HEMA |
| Target Indications | Cosmetic / Mild Astigmatism | Keratoconus, Dry Eye, Ectasia | Theatrical, Film, Special Effects |
| Regulatory Approval | CE Class IIa / ISO 13485 | CE Class IIb / Medical MDR | CE Class IIa / EU Directive |
Localized Market Scenarios
Serving Luxembourg’s Advanced Ophthalmic & Retail Network
Customized B2B manufacturing solutions mapped precisely to the clinical, therapeutic, and commercial demands of the Grand Duchy of Luxembourg.
Clinical Rehabilitation at Major Hospitals
Supplying specialized therapeutic scleral lenses to clinical centers such as the Centre Hospitalier de Luxembourg (CHL) and Hôpitaux Robert Schuman. Designed for advanced keratoconus management, corneal ectasia, post-corneal transplant optical correction, and severe ocular surface disease (Sjögren’s Syndrome).
Boutique Optometry & Pharmacy Retailers
Enabling independent optometrists and optical retail groups in Luxembourg City, Esch-sur-Alzette, and Differdange to market proprietary private-label eye care. We provide complete turn-key solutions including custom branded blister packs, localized French/German packaging, and multi-purpose care solution boxes.
Film, Media & Cultural Event Productions
Fulfilling bulk orders for specialized 22mm full-sclera cosmetic lenses for Luxembourg’s thriving film production hub (Filmland Kehlen) and theatrical arts industry. Guaranteed safe, opaque, non-toxic pigment encapsulation adhering to strict European cosmetic and medical safety protocols.
Market Intelligence
Luxembourg Market Trends & Regulatory Compliance Matrix
Navigating EU Medical Device Regulation (MDR) and local CNS reimbursement frameworks for seamless market access.
EU MDR 2017/745 Integration
All scleral and specialty contact lenses imported into Luxembourg must meet stringent Class IIa/IIb medical device regulations. Our factory maintains rigorous Technical Files, EUDAMED registration readiness, and UDI (Unique Device Identification) tagging to guarantee 100% compliance with Luxembourg’s Direction de la Santé - Division de la Pharmacie et des Médicaments.
CNS Reimbursement Alignment
In Luxembourg, custom therapeutic scleral lenses prescribed for severe ocular pathologies qualify for coverage under the Caisse Nationale de Santé (CNS). Our factory supports B2B partners by providing fully documented parameter certificates, lot traceability, and optical prescription validation required for national health code processing.
Green Supply Chain & Logistics
Leveraging Luxembourg-Findel Airport's status as a major European logistics hub, our supply chain guarantees rapid cargo transit. We implement eco-friendly, recyclable paperboard packaging for secondary containers, meeting Grand Duchy sustainability mandates and consumer preferences.
Factory Excellence
Why Global Brands & Luxembourg Buyers Partner With Us
End-to-end OEM/ODM manufacturing capability backed by international optical safety accreditations.
ISO 13485:2016 Certified Cleanrooms
Our state-of-the-art production facility operates under Class 10,000 (ISO Class 7) purified cleanroom environments, utilizing automated robotic blister packing, thermal sealing, and high-pressure steam autoclaving for 100% sterile batch output.
Full Private Label & OEM/ODM Support
From custom color shade development (1-tone, 2-tone, 3-tone, full sclera) to custom packaging layout, die-line design, and multi-lingual leaflet printing, we turn your brand vision into shelf-ready retail product lines.
Rigorous Spectrophotometric QC
Every lens lot undergoes strict optical power verification, spectrophotometric color fastness testing, edge-profile inspection, and hydration stability analysis to eliminate batch variance before dispatch.
Procurement FAQs
Frequently Asked Questions for Luxembourg B2B Buyers
Everything procurement officers, clinic directors, and optical distributors need to know about ordering custom scleral lenses.
What are the minimum order quantities (MOQ) for custom scleral lenses shipping to Luxembourg? +
For standard OEM/ODM soft contact lenses and stock specialty colored lenses, our minimum order quantity starts at 500 pairs per SKU. For custom clinical rigid scleral fitting trial sets or specialized prescription parameters, we accommodate low-volume pilot orders starting from 50 units to support optical fitting trials in Luxembourg clinics.
Are your sclera lenses fully compliant with European Union MDR regulations? +
Yes. All lenses manufactured at our facility adhere strictly to EU Regulation 2017/745 (MDR) for Class IIa/IIb medical devices and hold valid ISO 13485:2016 certification. Complete technical documentation files, Declarations of Conformity (DoC), CE certificates, and sterilization validation reports are provided for regulatory submission in Luxembourg.
How long does sample prototyping and delivery to Luxembourg take? +
Stock product samples are dispatched within 48 hours and arrive in Luxembourg within 3 to 5 business days via express air freight (DHL/FedEx to Luxembourg-Findel). Custom OEM private-label packaging and bespoke optical parameters typically require 15 to 20 working days for lathe setup, production, bio-compatibility testing, and shipping.
Can you produce multi-lingual packaging tailored to Luxembourg’s trilingual market? +
Absolutely. We specialize in localized artwork execution. Our graphic design team creates compliant secondary paperboard boxes, blister foils, and patient instruction leaflets featuring French, German, and English text simultaneously, ensuring seamless compliance across Luxembourgish retail channels.
What custom optical parameters can your factory manufacture for scleral lenses? +
We offer extensive custom manufacturing capabilities: Overall Diameters (OAD) from 14.0mm to 22.0mm, Base Curves (BC) from 6.50mm to 9.00mm, Sagittal Depths from 2,000µm to 5,500µm, Sphere powers from +20.00D to -25.00D, and Toric/Front-Surface Cylinder corrections up to -6.00D with customized peripheral landing zone adjustments.
How do you guarantee pigment safety in 22mm full sclera cosmetic lenses? +
We utilize proprietary "Sandwich Tech" micro-encapsulation technology. Biocompatible organic color pigments are fully sealed within inner hydrogel polymer layers. The pigment layer never comes into direct contact with either the cornea or the palpebral conjunctiva, guaranteeing maximum ocular safety and color vibrancy.
Expand Your Sclera & Ophthalmic Product Line Today
Partner with a trusted ISO 13485 & CE-certified contact lens manufacturer serving Luxembourg. Request our complete wholesale product catalog, technical specifications, and factory-direct pricing breakdown.