Certifications 

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UAE MOHAP

Obtains Ministry of Health & Prevention Approval

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ISO 13485:2016

Obtains ISO 13485:2016 Medical Device & Quality Management System

  • Manufacturing & Production

  • Research & Development 

  • Service Centre, Import & re export 

  • Non Active & Non Implantable Medical Scientific devices

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CE & EC REP 

Obtains Declaration of Conformity according to the Directive 98/79/EC

(Applicable to IVD Devices NOT Annex II and NOT self-test)

Harmonised standards:

EN ISO 13485:2016, EN ISO 14971:2019, EN ISO 17511:2003,

EN 13612:2002, EN ISO 23640:2015, EN ISO 18113-1:2011,

EN ISO 18113-2:2011, EN ISO 15223-1:2016, EN 62366:2008,

CLSI MM03-A2:2006, CLSI EP17-A:2004, CLSI EP07-A2:2005,

CLSI EP05-A2:2004

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WHO EUL 

Obtaining World Health Organisation Emergency Use Approval for:

  • Malaria PF/PV Smart Rapid Test Kit

  • Malaria Pf/Pan Smart Rapid Test Kit 

  • HIV A+B Smart Rapid Test Kit.

@ submission stage, expected by June 2021

UK MHRA

Obtaining UK MHRA Approval for:

  • COVID-19 Ag Smart Rapid Test Kit 

  • COVID-19 Ab Smart Rapid Test Kit 

@ submission stage, expected by May 2021

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US FDA EUA

AWBM  obtaining US FDA Emergency Use Approval for:

  • COVID-19 Ag Smart Rapid Test Kit 

  • COVID-19 Ab Smart Rapid Test Kit 

@ submission stage, expected by April 2021