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mdr-groovtube

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