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SZUTEST UYGUNLUK DEĞERLENDİRME A.Ş.
Friedrich-Ebert-Anlage 36, 60325 Frankfurt / / / GERMANY
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Contact Info: +49 69 244333026
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Hall: 3
Stand: 302A
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SZUTEST Konformitätsbewertungsstelle GmbH was founded in Frankfurt am Main in 2019 to carry out independent conformity assessment activities. SZUTEST Konformitätsbewertungsstelle GmbH is 100% owned by SZUTEST Conformity Assessment Inc. and combines more than 200 experienced employees and testing laboratory facilities. SZUTEST Conformity Assessment Body GmbH is designated as a Notified Body according to the Medical Device Regulation (EU) 2017/745 (MDR). We are a reliable partner in ensuring compliance and safety in the medical device industry. As a Notified Body (NB2975) designated under the Medical Device Regulation (MDR), we specialize in providing expert conformity assessment services that enable manufacturers to bring safe and effective medical devices to market. At SZUTEST Konformitätsbewertungsstelle GmbH, we are committed to maintaining the highest standards of quality and integrity in all our services. Our team of dedicated professionals has extensive knowledge and experience in the areas of regulatory affairs, clinical evaluation and technical documentation review. We look forward to working with you to ensure the safety and compliance of your medical devices. Thank you for choosing SZUTEST for your certification and conformity assessment needs. https//www.szutest-germany.de/
The CE marking indicates that the products comply with the provisions set out in the technical regulations of the EU and can be released into free circulation within the EU without. SZUTEST Konformitätsbewertungsstelle GmbH is recognized by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) and EU Commission, as a Notified Body with the identification number 2975 under the Medical Device Regulation (EU) 2017/745.
SZUTEST Uygunluk Değerlendirme A.Ş. is accredited by TÜRKAK for ISO 13485 certification activities.
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SZUTEST provides services with experienced personnel for many years as Notified Body in 93/42/EEC Medical Devices Regulation. Mechanical testing laboratory service is one the most efficient and reliable fields of our activities. SZUTEST services include static and fatigue testing according to ASTM standards or following your custom testing procedures especially for implants, prosthesis and sterilization packs. Our laboratory is accredited in the scope of EN ISO/IEC 17025 in Medical Devices area. We are using high quality and precise testing equipment, well known in the market (Instron-England, Shimadzu-Japan). Our customers benefit from more than 5 years of experience in implant testing.
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