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MICRO-X LIMITED — Regulatory Filings 2017
Mar 5, 2017
65388_rns_2017-03-05_8fa2b052-162f-4466-9e76-2d7b87ec9b4a.pdf
Regulatory Filings
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Micro-X Limited, 1284 South Road, Tonsley, Clovelly Park, South Australia, 5042
ABN: 21 153 273 735
Monday 6[th] March 2017
ASX Announcement – MICRO-X LIMITED (ASX: MX1)
Nano Commercialisation Update: ISO 13485 Accreditation
Micro-X Limited (ASX: MX1) is pleased to advise that it has successfully passed the documentation review which was a follow-up to the full ISO 13485 Stage Two Audit undertaken in mid-January. The auditor, BSI, has now recommended Micro-X for accreditation and the formal issue of the ISO 13485 accreditation certificate is expected within 6 weeks.
This is a major milestone in Micro-X’s development as it confirms that the company has established and is operating at its Tonsley facility a comprehensive Quality Management System for the design and manufacture of medical devices. Compliance with ISO 13485 is a material deliverable to achieve compliance with the EU Medical Device Directive.
Micro-X’s ultra-lightweight mobile X-Ray unit, the ‘DRX Revolution Nano’ was recently featured very successfully by Carestream Health at two important trade shows as part of the early marketing awareness campaign for the product. The very positive reactions from industry and clinical visitors to Arab Health in Dubai and the European Congress of Radiology in Vienna have confirmed strong interest in the Nano in these markets.
For further information please contact:
Mr Peter Rowland, Managing Director, Micro-X Limited
Telephone: +61 418 844 981 [email protected] www.micro-x.com
About Micro-X : Micro-X Limited (“ MX1 ”) is an Australian Securities Exchange listed company developing and commercialising a range of highly innovative products based on proprietary carbon nanotube emitter technologies exclusively licensed and sourced from XinRay Systems Inc., a US based technology developer. These technologies enable the miniaturisation of a number of X-ray applications relevant to large global markets.