Customers and certificates
Business Sector:
Software development (including software validation), Non-active non-implantable devices for anaesthesia, emergency and intensive care
Reference No.:
291656
Street No.:
100 Domain Drive
Zip, City:
03833, Exeter, NH
Country:
United States of America
Certified according to :
Scope:
Design, development, manufacturing, sales and distribution of respiratory humidification devices and accessories (disposable patient circuits, cannulas, adapters, compressors, transfer units, oxygen assist modules)
Certified according to :
Medical Devices VO (EU) 2017/745
Scope:
MDN 1201 - Non-active non-implantable devices for anaesthesia, emergency and intensive care ProSoft Nasal Cannula, Precision Flow Disposable Patient Circuit, Vapotherm Tranfer Unit, Precision Flow Water Bottle Adapter, High Velocity Nasal Cannulas MDA 0307 - Active non-implantable respiratory devices HVT 2.0
Certified according to :
ISO 13485:2016 (MDSAP Audit Model Edition 2)
Scope:
Design, development, manufacturing, sales and distribution of respiratory humidification devices and accessories (Disposable Patient Circuits, Cannulas, Adapters, Compressors, Transfer Units, , Oxygen Assist Modules) - AUS (a), BRA, CND, JPN, USA (a,b,c,d) REPs FEI No.: F000660