The Sun plastic & medial material industries co. ltd located in industrial Zone Aqaba building No. 139,77110 Jordon.
We are manufacturing and supply of In vitro diagnostic devices as per (Article 29 of the directive 98/79/EC on In vitro diagnostic medical devices) and also manufacturing General product safety devices as per (Article 1 of the directive 2001/95/EC), as fulfill the required ISO & internal quality standard within specific controlled clean room area class 7 & 8 (as per ISO CLASS 14644-1) and our finished product tested on various parameter to ensure that they comply with all of the above mention international quality standards & product standard ,
Our quality assurance system conforms to ISO:13485 and ISO:9001 standards encompassing a comprehensive and exhaustive series of visual, physical, chemical and bacteriological tests and inspection at various stages in the production cycle, beginning with constant surveillance of raw materials and its suppliers, intensive in-process control of all manufactured components and sub-assemblies to the final inspection and testing of the finished products.
The company having certified by the QMS ISO 9001:2015 & specific QMS for medical devices ISO 13485:2016,
Environmental management system ISO 14001:2015,
CE certification for (IVDD as per 98/79/EC),
Federal Agency for medicines and health product (FAMHP) imported requested country : KSA
GMP. Certification by the Jordon food and drug administration.