Company : Medica Middle East Medica Middle East Vision : Medica Middle East Mission : Medica Middle East Medica Middle East Medica Middle East

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1 MME Company Profile

2 Company : Medica Middle East is licensed as a Privet Free Zone Entity to facilitate its importing and exporting activities. Medica Middle East is a subsidiary of THIMAR Holding Group as a big organization with many various activities in different scopes. Vision : Medica Middle East vision is: 1. To manufacture high quality products to improve patients quality of life. 2. To provide our clients with the most effective medical device possible in a highly efficient time frame and at reasonable cost. Mission : Medica Middle East mission is divided into : Phase (1) : Where Medica Middle East developed and produced a top quality products of Dialyzers (Haemodialysis filters), Blood Lines (Arterial/Venous blood tubing sets) and Fistula Needles with a very wide range of availabilities and various models that covers market demands, meets physician requirements and assures patient safety. After achieving a certain level of stability, maturity and improvement Medica Middle East will develop to the next phase. Phase (2) : where Medica Middle East will enlarge its production capacity for the currently produced items and also will extend its production scope by developing and producing its own fiber membrane in collaboration with one of the reputable membrane manufacturers that will be directed to feed the dialyzer production lines and to provide other dialyzer manufacturers. Facility and Infrastructure : Huge facility constructed on 8000 m² with an extension for another 8000 m² dedicated for future expansionary plans. 2 classified clean rooms, ISO class 8 (class D), one for dialyzers manufacture and the other for blood lines and fistula needles production. Injection Area includes 14 injection machines to produce components required in dialyzers, blood lines and fistula needles production. Extrusion Area includes 1 extruder (upgradable to includes 2 more extruders) to produce tubes required in blood lines and fistula needles production. Sterilization Areas includes 4 sterilizers, 2 for EO gas sterilization and 2 other for Steam sterilization. Aeration and Degassing Area where EO degassing stage takes place to reduces the Ethylene Oxide residual down to the standard accepted limits. Quality Labs that includes the most advanced and developed equipments and instruments separated in biological, chemical and physical labs. Stores that designed and arranged to contain both raw materials and finished products in properly specified storage conditions. High production capacity that can introduce more than 4 Million dialyzers, 4 Million sets of arterial and venous blood lines and 7 Million pair of fistula needles per year. Such productivity can be

3 increased to be 5 Million dialyzers, 5 Million sets of arterial and venous blood lines and 8 Million pair of fistula needles per year only by applying 2 extended production shifts. Moreover, Medica Middle East also have the capability to enlarge its productivity by running 24/7 production. Certificates and Approvals : CE Certificates complying with Medical directive 93/42/EEC. ISO Certificates in accordance to ISO 9001 and ISO Compliance Certificate accredited by the National Quality Institute. Quality System : Intensive quality investigations for raw materials to assure material compliance for standard specifications. Firm and strict in-process control to confirm that production parameters are applied properly. Firm and strict environmental control to confirm that clean rooms behavior are within the acceptance limits all the time. Deep quality investigations for finished product to assure product quality. Strong and well established Quality Management System (QMS) built upon most updated international standards. Frequently close and tight monitoring for the Quality System implementation to assure proper applications. Documentary activities to assure proper reservation for process documents and records. Annual validation for critical processes and activities to support, grantee and approve such activities. Annual calibration for measuring devices to assure the credibility and accuracy of observed results. Process and Machinery: Well-designed production process with very precise and accurate production parameters to assure product high quality. Automatic and computerized production lines with a very sophisticated high technology. Automatic system for material feeding and automatic robots for product flow to reduce the biohazard risks. Personnel and Manpower: High expert calibers. Well trained labors.

4 Products Presentation 1. Dialyzer : High performance, superior clearance, excellent solutes removal and u reduction rates. Maximized high efficiency treatment. Approved biocompatibility. Most advanced membrane types supplied from one of the worldwide biggest membrane manufacturer. Materials and components provided from reliable suppliers to assure best quality. Laser technique use for sealing fiber and also for printing label. Different membrane types (Purema and Synphan) and various performances (High and Low Flux) to meet all patients requirements. Wide range of different surface areas (from 1.0 m² up to 2.6 m²) to offer wide availability to tailor the treatment on the patients needs. Available in all types of packaging as folded plastic package and sealed paper to plastic package. Sterilized with EO gas, Steam or Gamma sterilization. 2. Blood Line : Components provided from reliable suppliers to assure best quality. Color coded clamps (are available) to distinguish between arterial and venous lines. Tight clamps to secure an absolute termination of blood flow. PVC tubing produced of virgin medical PVC granules secure proper human biocompatibility. Assembly and gluing using high technology to assure prevention of blood flow blockage and inhibition of blood leakage hazards. Connections and joints suitable to fit all other Heamodialysis kits (dialyzer and fistula needles). Different models suitable for all available Heamodialysis machines. Custom made models are available to satisfy all customer requirements. Available in both single package or twin package. Sterilized with EO gas or GAMMA sterilization. 3. Fistula Needle: Fine and ultra sharp needle tip for puncture with minimum pain to assure patient comfort. Both arterial and venous needles are provided with back eyes to assure maximum blood flow with minimum vessel trauma. Rotating wings to provide an easy puncture and assure nursing comfort, also available fixed types. Color coded wings to distinguish different needle gauge sizes. Color coded clamps (are available) to distinguish between arterial and venous needles. Most advanced silicon coating to prevent blood coagulation and easy painless introduction. Tight clamps to secure an absolute termination of blood flow. Integrated safety needle protector (if required) to avoid needle stick injuries and to reduce infection risks.

5 PVC tubing produced of virgin medical PVC granules secure proper human biocompatibility. Soft and elastic tubing for suitable flexibility to offer proper function use. Available in both single package or twin package. Available in sizes: 15G, 16G, 17G. Sterilized with EO gas or GAMMA sterilization.