Eu Declaration Of Conformity; Certificates - Conroy Qseal-extra Operator's Manual

EU DECLARATION OF CONFORMITY

Legal Manufacturer:
Legal Manufacturer Address:
SRN (Single Registration Number):
Basic UDI-DI:
Name of the Device:
Product Code:
Intended purpose:
Classification and Rule:
Main standard:
We hereby declare that the medical device specified above meet the provision of
the Regulation (EU) MDR 2017/745 for medical device and Directive 2011/65/EU (RoHS).
This declaration is supported by the quality system approval to
This declaration of conformity is issued under the sole responsibility of Conroy Medical AB.
Upplands Vaesby, 2024-10-07
CS624 Qseal-extra Operator´s manual
Conroy Medical AB
Haesthagsvaegen 14A
SE-194 52 Upplands Vaesby
Sweden
SE – MF – 000027430
735011599103AF
Qseal-extra
CS624
Intended for sealing tubes and bags
in blood component sets.
Class I, according to Rule 1 in
Annex VIII of Regulation (EU) 2017/745
IEC 60601-1:2005 + AMD1:2012 + AMD2:2020
ISO 13485 issued by Intertek IMNB.
Place and date Nicklas Lundman, CEO
31