Surgitrac Instruments manufactures specialist surgical instruments

Quality & Credentials

All materials used conform to European and International Standards

These are our commitments to quality

Quality, credentials, and conformity

Quality is at the core of our manufacturing

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

Declaration of conformity

We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.

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Declaration of conformity

Reusable Non-sterile Stainless Steel class 1

Declaration of conformity

We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.

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Declaration of conformity

Reusable Titanium class 1

Declaration of conformity

We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.

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Instructions for Use (IFU)

Single-use instruments

Instructions for Use (IFU)

IFU document for Surgitrac Instruments single-use sterile ophthalmic.

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Instructions for Use (IFU)

Non-sterile instruments

Instructions for Use (IFU)

IFU document for Surgitrac Instruments non-sterile reusable instruments.

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Reprocessing Guidelines

Reusable surgical instruments

Reprocessing Guidelines

Surgitrac Instruments - reprocessing guideline UK version.

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ISO Surgitrac Instruments UK

EN ISO 13485:2003 and 13485:2012

ISO Surgitrac Instruments UK

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Quality Policy Statement

BS EN ISO 13485:2016

Quality Policy Statement

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Labour Standards Assurance System

Level 2 2018

Labour Standards Assurance System

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ISO Certification

Surgitrac Sihong

ISO Certification

Manufacture and disposal of disposable Ophthalmic instruments.

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EC Certification

Surgitrac Sihong

EC Certification

Awarding body TUV

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Product Certification

Surgitrac Sihong

Product Certification

Awarding body TUV

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Certificate Gamma Sterilisation

EN ISO 11137-1:2006

Certificate Gamma Sterilisation

Sterilisation of healthcare products.

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Certificate Gamma Sterilisation

Q4N 16 06 71270 001

Certificate Gamma Sterilisation

Gamma sterilisation of healthcare products.

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Certificate EO Sterilisation

Q4N 1604 59145 005

Certificate EO Sterilisation

Ethylene Oxide (EO) Sterilisation certificate single-use medical devices

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TUV Certification

Ophthalmic procedure packs

TUV Certification

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Declaration of Conformity

Latex free ophthalmic custom made packs

Declaration of Conformity

Declaration of Latex and DEHP free product /manufacturing

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