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Certificates

ISO 13485 : 2016

EN ISO 13485 : 2016: Valid from 2024.07.06 until: 2027.07.05

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ISO 13485 : 2016 (MDSAP Audit Model Edition 2)

MDSAP16 Valid from 2022.03.21 until: 2027.06.12 

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EC-CERTIFICATE

MR2 EC-Certificate Valid from 2021.05.22 until 2024.05.26 / Extended 2027.12.31 / 2028.12.31

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EC-CERTIFICATE Extension
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EU Quality Management Certificate

MDR2017Q Valid from 2025.10.24. until 2028.09.26 

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EU Technical Documentation Assessment Certificate for PFR Meshes, transvaginal

066924 MDR2017P : Valable du 31/07/2025 au 30/07/2030

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Documentation technique UE Certificat d'évaluation pour les mailles PFR, transabdominales

066924 MDR2017P : Valable du 24 octobre 2025 au 24 octobre 2030.

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A.M.I.  Agency for Medical Innovations GmbH
Im Letten 1
6800 Feldkirch

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vigilance@ami.at

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