Quality & Credentials
Surgitrac® product quality assurance
Surgitrac Instruments product quality is at the core of our manufacturing processes. We have robust systems in place to ensure the consistent quality of our surgical instruments. Products are subject to a rigorous quality checking process, from development through to the final production.
Our CE-marked single-use and reusable surgical instruments are subject to several inspections, during the manufacturing process. All of our instruments are batch and lot identifiable in line with the internationally recognised standards.
Click here for Ophtec Instructions for Use (IFU) in various languages
Device-specific IFU is available on request.
You can view our relevant credentials below.
Quality, credentials, and conformity
Compliant with MDR, EU and International Standards
These are our commitments to quality
Declaration of Conformity 2021 -2024
Class 11a
Declaration of Conformity 2021 -2024
Non-sterile single use
ISO Surgitrac Instruments UK
EN ISO 13485:2016
ISO Certification Sihong
EN ISO 13485:2016
EC Certification Surgitrac Sihong
EN ISO 13485:2016
Awarding body TUV
Reprocessing Guidelines
Reusable surgical instruments
Surgitrac Instruments – reprocessing guideline UK version.
Quality Policy Statement
BS EN ISO 13485:2016
Labour Standards Assurance System
2020
Nuline EC Certification
G2S 101488 0002
Nuline ISO 9001
ISO 9001:2015
Awarding body TUV
Nuline ISO 13485
EN ISO 13485:2016
Awarding body TUV
Fuqing CE Consumables
G2S 037314 0041
Fuqing EC Certification
G1 037314 0042
Fullcare ISO Consumables
EN ISO 13485:2016
Awarding body TUV
FAQ — Quality & Credentials
What quality standards does Surgitrac comply with?
Surgitrac operates under ISO 13485 medical device quality management standards and maintains robust quality assurance systems, ensuring safety, reliability, and consistent performance in all its ophthalmic instruments.
Are Surgitrac products CE marked?
Yes. All Surgitrac surgical instruments are CE marked and manufactured to internationally recognised medical device standards, ensuring safety, compliance, and confidence for healthcare providers worldwide.
How does Surgitrac ensure product consistency and traceability?
Surgitrac maintains strict quality control procedures, batch traceability systems, and supplier audits, ensuring every instrument is consistently manufactured and fully traceable for safety and reliability.
Can Surgitrac support hospital and NHS procurement requirements?
Yes. Surgitrac’s certifications and compliance systems are tailored to meet NHS, hospital groups, and international procurement requirements, ensuring confidence for eyecare providers.
