Global Certifications You Can Trust
Globally Certified, Professionally Trusted — CE, FDA, ISO 9001 & 13485 Approved Optometry & Ophthalmic Equipment.
In the ophthalmic field, certification means trust. LINK’s products are fully approved by CE, FDA, ETS, ISO9001, and ISO13485, meeting global safety and performance standards.
LINK Instrument understand how critical certifications are for market access and hospital registration. That’s why we provide complete documentation and full support for your local FDA or CE registration, helping you save time and avoid regulatory risks.
FDA
FDA certification is a validation indicating that a product has met the stringent safety, performance, and quality standards set by the U.S. and is approved for sale in the US.
Obtaining FDA approval reflects LINK’s continuous commitment to product excellence, regulatory compliance, and patient safety. It enables our devices — from Auto Refractometers and Slit Lamps to Phoropters and Tonometers — to be confidently used by eye care professionals in hospitals, clinics, and optical centers across the United States and worldwide.
ISO 9001
ISO 9001 is a globally recognized standard for quality management.
By implementing ISO 9001 principles, LINK guarantees stable product quality, efficient production management, and reliable customer support. From material selection to final inspection, every product — including our Auto Refractometers, Slit Lamps, and Refraction Units — is produced under a well-defined quality framework that ensures precision, safety, and long-term performance for global eye care professionals.
ISO13485
The ISO 13485 certification focuses on the safety, traceability, and regulatory compliance required in the design and production of medical instruments.
Through strict implementation of ISO 13485, LINK maintains controlled production environments, precise testing procedures, and complete documentation systems for all devices, including Auto Refractometers, Phoropters, and Slit Lamps. This allows us to deliver reliable, compliant, and high-performance ophthalmic and optometric equipment that doctors and clinics can trust worldwide.
optometrists equipment CE
CE Certification confirms optometric instruments meet EU Medical Device Regulation (MDR 2017/745), ensuring accuracy, safety, and regulatory compliance.
LINK’s Optometric devices — including Auto Refractometers, Lensmeters, and Phoropters — are CE certified for precision, safety, and reliable clinical performance, supporting trusted eye care worldwide.
Ophthalmic Table CE
CE Certification confirms optometric instruments , ophthalmic tables comply with EU machinery and electrical safety standards, guaranteeing stable and safe operation in clinics.
LINK’s Ophthalmic Tables — motorized tables, refraction units, and chairs — are CE certified for mechanical safety, durability, and reliable performance, giving professionals confidence in daily clinical use.
Refractometer CE
CE Certification confirms that refractometers comply with EU Medical Device Regulation (MDR 2017/745), ensuring safety, accuracy, and regulatory compliance for clinical use.
LINK’s Auto Refractometers are CE certified, guaranteeing precise measurements, safe operation, and reliable performance.
LCD Vision Chart CE
CE Certification ensures that LCD Vision Charts meet EU Medical Device Regulation (MDR 2017/745) requirements, guaranteeing safe, reliable, and accurate vision testing in clinical settings.
LINK’s LCD Vision Charts are CE certified, providing precise visual acuity testing, user-friendly operation, and consistent performance.
