Quality, credentials, and conformity
Compliant with MDR, EU 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 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.
Declaration of Conformity 2021
Class 11a
Declaration of Conformity 2021
Non-sterile single use
EC Representative Cert
Advena
ISO Surgitrac Instruments UK
EN ISO 13485:2016 and 13485:2016
ISO Certification Sihong
EN ISO 13485:2016
EC Certification Surgitrac Sihong
EN ISO 13485:2016
Awarding body TUV
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.
Quality Policy Statement
BS EN ISO 13485:2016
Labour Standards Assurance System
2020
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
GA Health Company
TUV Certification
Ophthalmic procedure packs
TUV Certification
Class I medical devices
Declaration of Conformity
Latex free ophthalmic custom made packs
Declaration of Latex and DEHP free product /manufacturing
TUV Certification
Class IIa IIb III medical devices
Reprocessing Guidelines
Ophtec Instruments
IFU DO2 40/DO2 70/DO2 72/DO2 74/PF105/OF106
Ophtec Instruments
IFU DO6 41 ARTISAN Manipulator standard straight
Ophtec Instruments
IFU OF115 ARTIFLEX Manipulator
Ophtec Instruments