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Iso 13485 certified - Turkey

4 Companies

4 Products

PROSIM MEDICAL

Turkey

Prosim Medical, through its CYTRONICS brand, is an industry pioneer with a prolific production capacity. Via World standards prodution validity proven by customer satisfaction and manufacturing top quality orthopedic products and instruments, the company has become a worldwide brand. Prosim means a service based on a system with a high Standard of quality. We are constantly innovating and have aimed to continually improve our organization to be the best in the sector with our R&D and technological investments with our research universities and specialist surgeons. Prosim is an ISO 13485 certified company and all of the products are produced under CE Mark. Quality is always our first priority. The quality control department is equiped with CMM, profile projectors, Hardness measuring device among others. With our experienced staff, a high Standard of quality and best machine parkour in the country, we continue to lead the trauma orthopaedic implants market for more than two decades. Our machining departments includes swiss turning machines, CNC turning machines and milling machines where we manufacture locking and non-locking screws, instruments, straight and anatomic bone plates and similar products. Our bone plates re either wire cut with our cutting edge wire cutting machines or forged in our forging factory. At Prosim, we are driven to provide our custormers the best services at the right time at the lowest cost.
DISERA MEDICAL EQUIPEMENT

Turkey

Our production and sales activities have expanded since DISERA's inception in 1996. The product portfolio for the 2004 investment included Petri dishes, sharp boxes, vaginal speculums, and urine beakers. Our production investment reached a new level in 2014 as a result of the production of evacuated vacuum tubes. VACUSERA vacuum blood collection tubes are the result of advanced manufacturing technology and diagnostic experience. We moved to a new factory building in Turkey's Tire Organized Industrial Area in 2014. The entire manufacturing process adheres to ISO 13485: 2016 quality management systems, and all products bear the CE mark. We provide manufacturing services in accordance with ISO 13485: 2016 quality standards and have knowledge and experience in providing high-quality, technical medical products that meet the needs of the healthcare sector. Vacusera Blood Collection Tubes, for example, are CE marked in accordance with Directive 98/79/EC on In Vitro Diagnostic Devices. Vacusera Blood Collection Tubes are manufactured in accordance with ISO 6710 and EN 14820 standards. Furthermore, Vacusera Blood Collection Needles are CE certified and manufactured in accordance with 93/42/EEC regulations. To increase our production volumes, we invest in new facilities. We are aware of the current global market demand for laboratory consumables. Furthermore, this demand will grow in the future.

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OKUMAN MEDIKAL SISTEMLER A.S.

Turkey

OKUMAN (officially: OKUMAN Medikal Sistemler A.S.) is a world-class incorporated company, established in Ankara/Turkey as R&D and Production Company with 35- year experience and highly skilled team members for Hospital Equipment. OKUMAN designs, manufactures and distributes the following products and systems for Maternal & Infant Care, ICU and Anesthesia; • Infant Incubator • Transport Incubator • Infant Warmer • Infant Ventilator • Infant Phototherapy Unit • ICU Ventilator • Patient Monitor • Defibrillator • Anaesthesia Unit • Operating Lamp • Operating Tables Additionally, OKUMAN has completed several local and international turn-key hospital projects in Niger, Benin, Kenya, Georgia, Azerbaijan, Moldovia, etc. recently with its dedicated Hospital Project Team. OKUMAN is certified to CE, ISO 13485 and ISO 9001 standards and audited regularly by notified body. Therefore, OKUMAN constantly reviews its product design, manufacturing processes and systems and training procedures to ensure its customers for better patient care. Last but not least, OKUMAN believes that, the relation doesn’t end with the delivery of the products, on the contrary, long-term partnerships just starts between OKUMAN and Customers with the delivery of the products.
VITROSENS BIOTECHNOLOGY LTD.

Turkey

Vitrosens Biotechnology is a high-tech manufacturing facility in Turkey which integrated R&D, production, and sales. The company was founded at the beginning of 2020. Since then, it becomes a reliable manufacturer of the Covid-19 rapid diagnostic test kit. Our manufacturing center, located in Istanbul, Turkey, is a rapidly growing manufacturing center for IVD (in-vitro-diagnostic) products and new product development. Vitrosens Biotechnology has established a comprehensive Quality Management System that applies international standards (EN ISO 13485), ensuring top quality test results and accuracy. Also, most of our products are CE certified. Vitrosens Biotechnology is one of the leading Turkish manufacturers of Covid-19 Rapid Test Kit sold in Europe. Vitrosens Biotechnology aims to provide the world with high-quality lateral flow IVD test products. Our cost-effective lateral flow test kits play an important role in point-of-care diagnosis for coronavirus disease. Vitrosens Biotechnology provides healthcare professionals and individuals with easy-to-operate rapid test cassettes for fast and effective diagnosis of related disease. Vitrosens Biotechnology has launched SARS-CoV-2 RapidFor ™ Antigen Rapid Test Kit and SARS-CoV-2 RapidFor ™ IgG/IgM Antibody Rapid Test Kit in the International and Turkish markets, more than a million accurate Covid-19 test kits have been delivered worldwide, to combat the Covid-19 pandemic.

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Iso 13485 certified - Turkey

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