Customers and certificates

Vapotherm Technology Asia Pte Ltd.

Business Sector:
Non-active device for anaesthesia, emergency and intensive care, Software development (including software validation)
Reference No.:
31622225
Certified according to :

EN ISO 13485:2016 / A11:2021

This certification belongs to the parent company 291656 Vapotherm, Inc.

Scope:

Design and Development of Breathing Support Devices and Disposable Patient Circuit, Patient Interfaces including Nasal Cannulas

Certified according to :

ISO 13485:2016 (MDSAP Audit Model Edition 2)

This certification belongs to the parent company 291656 Vapotherm, Inc.

Scope:

Design and development 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.: F007416