Quality & Credentials
All materials used conform to European and International Standards
These are our commitments to quality
All materials used conform to European and International Standards
These are our commitments to quality
Surgitrac® product quality assurance
Surgitrac® Instruments product quality is at the core of our manufacturing processes
We have robust systems in place to ensure a 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.
We hand finish and inspect each surgical instrument that we manufacture.
All of our instruments are batch and lot identifiable in line with the internationally recoginsed standard: EU Directive 93/42/EEC Quality Assurance: Medical Devices.
EC Declarations of Confomtiy and device specific IFU’s available on request.
You can view our relevant credentials below
We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.
We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.
We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.
IFU document for Surgitrac Instruments single-use sterile ophthalmic.
IFU document for Surgitrac Instruments non-sterile reusable instruments.
Surgitrac Instruments - reprocessing guideline UK version.
Manufacture and disposal of disposable Ophthalmic instruments.
Awarding body TUV
Awarding body TUV
Sterilisation of healthcare products.
Gamma sterilisation of healthcare products.
Ethylene Oxide (EO) Sterilisation certificate single-use medical devices
Declaration of Latex and DEHP free product /manufacturing