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Our Standards & Accreditations

Standards & Accreditations

A pioneer for medical device quality

Oxylitre is accredited to ISO 13485:2016, ISO 9001, & Directive 93/42/EEC Please click on the tabs below to view the relevant certification.

Oxylitre is also proudly compliant to the Waste Electrical & Electronic Regulations 2013
WEEE Account No: 331230.
WeeCare Plc: help line no: 0330 331 1801
WEEE Certificate No: WEE/MM4847AA

Medical Device Directive

Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

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Extension Letter

EN ISO 13485:2016

Quality Management System - ISO 13485:2016 & EN ISO 13485:2016

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ISO 9001:2015

Quality Management System - ISO 9001:2015

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Waste Electrical & Electronic Regulations 2013

Waste Electrical & Electronic Regulations 2013

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