EU DECLARATION OF CONFORMITY
Legal Manufacturer: Conroy Medical AB
Legal Manufacturer Address: Haesthagsvaegen 14A
SE-194 52 Upplands Vaesby
Sweden
SRN (Single Registration Number): SE – MF – 000027430
Basic UDI-DI: 735011599103AF
Name of the Device: Qseal-auto
Product Code: CS524
Intended purpose: Intended for sealing tubes and bags
in blood component sets.
Classification and Rule: Class I, according to Rule 1 in
Annex VIII of Regulation (EU) 2017/745
Main standard: IEC 60601-1:2005 + AMD1:2012 + AMD2:2020
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
ISO 13485 issued by Intertek IMNB.
This declaration of conformity is issued under the sole responsibility of Conroy Medical AB.
Place and date
Upplands Vaesby, 2024-10-07
Nicklas Lundman, CEO
31
CS524 Qseal-auto Operator´s manual
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