Quality, credentials, and conformity
All materials used during manufacturing 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
Declaration of conformity
Single-use class 1
We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.
Declaration of conformity
Reusable Non-sterile Stainless Steel class 1
We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.
Declaration of conformity
Reusable Titanium class 1
We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.
Instructions for Use (IFU)
Single-use instruments
IFU document for Surgitrac Instruments single-use sterile ophthalmic.
Instructions for Use (IFU)
Non-sterile instruments
IFU document for Surgitrac Instruments non-sterile reusable instruments.
Reprocessing Guidelines
Reusable surgical instruments
Surgitrac Instruments - reprocessing guideline UK version.
ISO Surgitrac Instruments UK
EN ISO 13485:2016 and 13485:2016
Quality Policy Statement
BS EN ISO 13485:2016
Labour Standards Assurance System
Level 2 2018
ISO Certification
Surgitrac Sihong
Manufacture and disposal of disposable Ophthalmic instruments.
EC Certification
Surgitrac Sihong
Awarding body TUV
Product Certification
Surgitrac Sihong
Awarding body TUV
Certificate Gamma Sterilisation
EN ISO 11137-1:2006
Sterilisation of healthcare products.
Certificate Gamma Sterilisation
Q4N 16 06 71270 001
Gamma sterilisation of healthcare products.
Certificate EO Sterilisation
Q4N 1604 59145 005
Ethylene Oxide (EO) Sterilisation certificate single-use medical devices
TUV Certification
Ophthalmic procedure packs
TUV Certification
Class I medical devices
TUV Certification
Class IIa IIb III medical devices
Declaration of Conformity
Latex free ophthalmic custom made packs
Declaration of Latex and DEHP free product /manufacturing