MDR information for GroovTube
This page provides information for resellers of the GroovTube breathing exerciser device in compliance with Medical Devices Regulation MDR 2017/745.
Legal Manufacturer
Audio Rhoon
Marskramer 17
3161 ND Rhoon
Netherlands
EUDAMED Single Registration Number (SRN)
NL-MF-000006073
Company Registration Number
KvK Rotterdam NL 51845296
SRN (Single Registration Number): NL-MF-000006073
Basic UDI-DI: 87193268503GROOVF9
Device Global Trade Identification Number (GTIN): 8719326850306
Unique Device Identifier (UDI): 8719326850306 + Device serial Number
Global Medical Device Nomenclature (GMDM)
Description: Incentive spirometer
Code: 31266
FARMATEC
Aanmelding medisch hulpmiddel GroovTube NL-CA002-2015-33786
Notified Body/Competent Authority (CA):
Agentschap CIBG
Medische hulpmiddelen en exportverklaringen
Wijnhaven 16 | 2511 GA | Den Haag
Postbus 16114 | 2500 BC | Den Haag
HS code
9019.20.00
therapeutisch ademhalingstoestel
therapeutic respiration apparatus
Applied standards
MEDDEV 2.7.1 – Guidelines on Medical Devices / Clinical Evaluation: A guide for manufacturers and Notified Bodies
ISO 14971 – Medical devices – Application of risk management to medical devices.
EN60601-1-2: (2011) Medical electrical equipment – Electromagnetic disturbances
EN 55016-2-3 (2010) & A1 (2010) – Emissions
EN61000-4-2 (2009) – Electrostatic discharge
EN61000-4-3 (2006) – Immunity
Declaration of Conformity
Declaration of Conformity GT June 2021
User Manual
https://www.groovtube.nl/wp-content/uploads/2018/01/GroovTube-Manual-EN-v8-webversion.pdf
Intended Use
The GroovTube is a breathing exerciser that makes breathing and oral motor skills visible on an iPAD. It turns your breath into real-time image effects, for use by people with breathing, speech, or oral motor disabilities.
Additional Information
Electronic assembly management system (QMS) fulfills the requirements of ISO 9001:2015