Re-Meeting FDA Requirements to Produce Rooyagen PRP Kit


Re-Meeting FDA Requirements to Produce Rooyagen PRP Kit

Specialists and basic scientists of Rooyagen in Aria Mabna TashKhis Co. using European and American medical grade raw materials while obtaining various internal licenses (health reference laboratory, injection confirmation of Pasteur Institute of Iran, …) The first Iranian kit Is that all international standards for the production of PRP kits such as:

  • 93 EC93 / 42 (Essential requirements for medical devices)
  • ISO 9001: 2015 Quality management system
  • ISO 13485: 2016, Medical devices Quality management system
  • ISO 14971 Safety of medical devices
  • ISO 10993 (1,3,4,5,7,10,11)

Has succeeded in re-meeting the requirements of the US Food and Drug Administration (FDA) in obtaining cGMP system management standards (FDA QSR 21 CFR 820) in the production of PRP kits by 2025.

  Finally, according to clinical results, published articles and scientific citation that have led to the widespread acceptance of this product in the country are also exported to foreign markets. Congratulations to the manufacturers of knowledge-based medical equipment and the scientific and medical community of the country for achieving these successes, and we sincerely thank all those who have worked hard in this difficult way to produce products with internationally accepted standards.

Best regards

Rooyagen Scientific Group




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About us

  • Rooyagen brand (ROOYA GEN) owned by Aria Mabna TashKhis -Knowledge based -Company, was born in 2010. Rooyagen, while entering the field of medical device production, became the first platelet processing and concentrating (PRP) kit in Iran after obtaining the relevant licenses. The first product in the Rooyagen PRP kit was for musculoskeletal use.

  • From the beginning of 2013, Rooyagen was able to launch another product in the field of skin rejuvenation and hair loss treatment. One of the honors of the Rooyagen brand is active participation in scientific and academic forums. The products of this brand have been cited in several (more than 50) scientific articles and have received over 1000 referral citation from scientific studies.

  • Following the path of research and development in 2016, another product of Rooyagen was produced for the treatment of chronic wounds. This kit was produced as a platelet gel with high durability and Sustain release technology and brought brilliant results. Accompaniment of professors of Tehran University of Medical Sciences - Shariati Hospital was published and is now available in clinics for the treatment of diabetic wounds and other chronic wounds

  • Simultaneously with achieving promising results for the treatment of infertility worldwide, Rooyagen product for infertility uses such as recurrent miscarriage and thin endometrium, has successfully passed its research and development stages and with the cooperation of professors of Taleghani Hospital- Beheshti University of Medical Sciences It has been clinically proven and its results have been published in authoritative ISI articles. Fortunately, today most infertility centers in the country are using this product to help infertile couples. we are proud continuing this path with your support and enthusiasm for new services to patients in need ...

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Unit 1, No.11,setayesh, satarkhanSt., Tehran.

+98 66512800

Info[@]Rooyagen.com


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