Our Certifications
PrecisPharma is proudly certified by the leading quality registrar, TÜV SÜD. Our Quality Management System is recognized with the following certifications:
EN ISO 13485:2016
EN ISO 13485:2016 for Production and supply of Dosing syringes & Measuring Cups for oral dispensing of medicines.
ISO 15378:2017
ISO 15378:2017 for Production and Supply of plastic bottles and closures as primary packaging materials by molding for pharmaceutical use.
US FDA Type III DMF
US FDA Type III DMF holder (DMF No. 034858)
European Medical Device Regulation
European Medical Device Regulation 2017/745 on medical devices.
IMDR Licence
IMDR Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device – License No. MFG/MD/2025/000180
Canadian Type II DMF
Canadian Type II DMF Dossier ID:
1.Bottles and Containers - e293465
2.Caps and Measuring Cups - e293468
3.Dosing Syringe and Adapter - e293647