A.M.I. Agency for Medical Innovations GmbH

MDD Confirmation Letter

Design and Development, Manufacturing and Distribution of medical devices for Coloproctology, Oncology, Laparoscopy, Morbid Obesity, Gynaecology/ Urogynaecology and Urology -AUS (a), BRA, CND, USA (a,b,c,d) REPs FEI No.: F000632

Design and Development, Manufacturing and Distribution of non-active functional implants and soft tissue implants, active surgical devices, non-active instruments and non-active devices for injection, infusion, transfusion and dialysis in the medical fields of Coloproctology, Gynaecology/ Urogynaecology, Laparoscopy, Morbid Obesity, Oncology and Urology.

- MDN 1208 - Non-active non-implantable instruments [AHK 007-A.M.I. HAL Knotpusher]; - MDN 1208 - Non-active non-implantable instruments [K6601-disposable Knotpusher]; - MDN 1208 - Non-active non-implantable instruments [RAR2081-RAR Flexi Probe]; - MDN 1208 - Non-active non-implantable instruments [IST1010 - i-Stitch]; - MDN 1208 - Non-active non-implantable instruments [IST1040 - i-Stitch up]: - MDN 1208 - Non-active non-implantable instruments [IGY-BAR - InGYNious Bar]; - MDN 1208 - Non-active non-implantable instruments [ATS5010 - ATOMS Tunneller]; - MDN 1208 - Non-active non-implantable instruments [TOA5130 - A.M.I. TOA Tunneller]; - MDN 1208 - Non-active non-implantable instruments [TVA5030 - A.M.I. TVA Tunneller]; - MDN 1208 - Non-active non-implantable instruments [AHN 006 - A.M.I. HAL Needleholder]; - MDN 1208 - Non-active non-implantable instruments [TRI2070 - TRI2070 – WI-3-Arm; - MDN 1208 - Non-active non-implantable instruments [CDS2010 - Comfort Drain Grasper]; - MDN 1208 - Non-active non-implantable instruments [MCS5111 - More-Cell-Safe]; - MDN 1208 - Non-active non-implantable instruments [MCS5151 - More-Cell-Safe 30]; - MDN 1208 - Non-active non-implantable instruments [MCS5131 - More-Cell Bag]; - MDN 1208 - Non-active non-implantable instruments [FIX2001 - FiXcision]; - MDN 1208 - Non-active non-implantable instruments [TRI2011 - Wi-3 Probe]; - MDN 1208 - Non-active non-implantable instruments [TRI2090 – Spacer Trilogy]; - MDN 1104 - Non-active soft tissue and other implants [PFR Meshes, transvaginal]; - MDA 0312 - Other active non-implantable surgical devices ICT5011 - i-Cut, TRI2010 - Wi-3 HAL-RAR Unit

MDN 1104 - Nicht aktive Weichteil- und sonstige Implantate