Quality & Credentials

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 -2024

Class 11a

Declaration of Conformity 2021 -2024

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Declaration of Conformity 2021 -2024

Non-sterile single use

Declaration of Conformity 2021 -2024

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EC Representative Cert

Advena

EC Representative Cert

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ISO Surgitrac Instruments UK

EN ISO 13485:2016 and 13485:2016

ISO Surgitrac Instruments UK

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ISO Certification Sihong

EN ISO 13485:2016

ISO Certification Sihong

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EC Certification Surgitrac Sihong

EN ISO 13485:2016

EC Certification Surgitrac Sihong

Awarding body TUV

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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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Quality Policy Statement

BS EN ISO 13485:2016

Quality Policy Statement

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Labour Standards Assurance System

2020

Labour Standards Assurance System

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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

GA Health Company

TUV Certification

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TUV Certification

Ophthalmic procedure packs

TUV Certification

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TUV Certification

Class I medical devices

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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TUV Certification

Class IIa IIb III medical devices

TUV Certification

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