Medical Device Manufacturer Catalog No.8008

Medical Device Manufacturer Catalog No.8008

OROSOL® can produce medical device – Ophthalmic & Sports Protective Eyewear.

Item Name: OROSOL® Ophthalmic & Sports Protective Eyewear.

Brand: OROSOL®

OROSOL® can produce all kinds of medical devices.

If you are interested in this product, please feel free to contact us: RoboticWorkCell@outlook.com

Product Description

Medical Device Manufacturer Catalog No.8008

General View of OROSOL® Manufacturer No.8008:

OROSOL Machinery and Equipment Manufacturing LLP is located in China, with Manufacturer No.8008 a modern manufacturing facility spanning over 30,000 square meters. The company employs more than 500 professional staff members, including a dedicated R&D team of over 60 engineers and technicians specializing in optical lens technology and protective eyewear development. The company specializes in the production of ski goggles, sports protective glasses, medical goggles, swimming goggles, sunglasses, reading glasses, and optical lenses. The company operates an in-house mold design and manufacturing center, an injection molding workshop, an automated assembly line, and professional laboratories. Products are exported to more than 40 countries worldwide, including the United States, Germany, Italy, Australia, Japan, and South Korea.

Medical Device Product Catalog No.8008:

Product Category Product Name & Model Parameters & Specifications Features & Applications
Medical Protective Eyewear OS-MG-100 Medical Protective Goggle Material: High-impact polycarbonate lens; Anti-fog coating; Adjustable elastic headband; Ventilation system to prevent fogging; CE and FDA certified; Available in clear and tinted lenses; UV400 protection; Meets ANSI Z87.1 and EN 166 standards. Medical protective goggle designed for healthcare professionals in high-risk environments. Provides protection against fluid splashes, airborne particles, and biological hazards. Suitable for hospital wards, laboratory work, dental procedures, and emergency medical services.
Medical Protective Eyewear OS-MFS-200 Medical Face Shield Material: Optical-grade PETG sheet; Adjustable headband with foam forehead cushion; Anti-fog and anti-static coating; Provides full face protection; Replaceable shield sheet; Lightweight design; CE and FDA certified. Medical face shield designed for healthcare professionals requiring full-face protection. Provides barrier protection against fluid splashes, droplets, and airborne contaminants. Suitable for surgical procedures, emergency response, and high-risk clinical settings.
Sports Protective Eyewear OS-SG-300 Ski Goggle Frame: TPU material for cold weather flexibility; Dual-layer lens with anti-fog coating; 100% UV protection (UV400); Multi-layer foam for comfort and fit; Airflow ventilation system; Helmet-compatible design; Interchangeable lens options. Professional ski goggle designed for winter sports enthusiasts and athletes. Provides superior optical clarity, UV protection, and anti-fog performance. Suitable for skiing, snowboarding, and other winter activities.
Sports Protective Eyewear OS-SG-400 Sports Protective Glasses Frame: TR-90 lightweight material; Polycarbonate impact-resistant lenses; Interchangeable lens design; UV400 protection; Anti-slip nose pads and temple tips; Prescription-compatible; CE and FDA certified. Versatile sports protective glasses for various athletic activities including cycling, running, tennis, and outdoor sports. Provides comprehensive eye protection with style and comfort.
Swim & Water Sports Eyewear OS-SW-500 Swimming Goggles Frame: Soft silicone or PVC material; Polycarbonate lens with UV protection; Anti-fog coating; Watertight seal; Adjustable headband; Available in multiple colors and styles; Suitable for competitive and recreational swimming. Professional swimming goggles for competitive swimmers and recreational users. Provides clear underwater vision, protection against chlorine and saltwater, and secure fit for comfortable swimming experience.
Ophthalmic & Vision Solutions OS-RL-600 Reading Glasses Lens: Optical-grade material; Available in various diopters (+0.50D to +4.00D); UV400 protection; Anti-reflective and scratch-resistant coating; Lightweight frames; Spring hinges for comfort; CE and FDA certified; Available in multiple styles and colors. Ready-to-wear reading glasses for presbyopia correction. Provides clear near vision for reading, computer work, and detailed tasks. Suitable for daily use at home, office, and on-the-go.
Ophthalmic & Vision Solutions OS-SG-700 Sunglasses Lens: Polycarbonate with UV400 protection; Polarized or standard tint options; Anti-reflective and scratch-resistant coating; TR-90 or metal frames; Available in multiple styles and colors; CE and FDA certified. Fashion and performance sunglasses providing complete UV protection. Suitable for daily wear, driving, outdoor activities, and sports. Offers both style and eye protection.
Ophthalmic & Vision Solutions OS-OL-800 Optical Lenses Material: CR-39, Polycarbonate, or Trivex; Available in single vision, bifocal, and progressive designs; Anti-reflective, scratch-resistant, and UV coating options; Customizable to prescription; Available in clear, tinted, and photochromic versions; CE and FDA certified. High-quality optical lenses for prescription eyewear. Manufactured with precision to meet various vision correction needs. Suitable for use in medical eyewear, daily glasses, and specialized vision solutions.

Certificates of OROSOL® Medical Device Manufacturer 8008:

  • ISO 13485:2016 — Medical Devices Quality Management System (Certified)
  • ISO 9001:2015 — Quality Management System (Certified)
  • FDA 510(k) Clearance — Medical Protective Eyewear (Class I/II)
  • CE Marking (MDR 2017/745/EU) — Compliance with European Medical Device Regulation
  • ANSI Z87.1 — American National Standards Institute (Impact Protection Standard)
  • EN 166 — European Standard for Personal Eye Protection
  • NMPA Medical Device Filing — Class I Medical Device Filing
  • GMP Certification — Good Manufacturing Practice for Medical Devices (China NMPA)
  • National High-Tech Enterprise Certification (China)
  • Xiamen “Specialized and Sophisticated” Enterprise Certification
  • RoHS Compliant — Restriction of Hazardous Substances Directive (EU)
  • REACH Compliant — Registration, Evaluation, Authorization and Restriction of Chemicals (EU)

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