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DECLARATION OF CONFORMITY
Declaration of Conformity Annex VII EU Directive 93/42/EEC
We, as company: Harvest Healthcare Ltd
Sheaf House
Bradmarsh Way
Bradmarsh Business Park
Rotherham, S60 IBW
Product Development and Quality Manager
Rotherham, 23.03.2020
Confirm on our own behalf that the medical product:
Harvest Pump 1 - HPU1 - UDI: 5060517530150
Risk Class: IIa
SRN:
TBC
complies with all applicable requirements in Appendix I of the EU directive 93/42E EC
The following compliance evaluation process was applied: Annex VII
EU legislation for this type of product covers all safety, health and environmental requirements.
Modifying this product without consultation with Harvest Healthcare Ltd will invalidate this declaration
of conformity.
This declaration of conformity is issued under the sole responsibility of Harvest Healthcare.
Notified Body: TBC
This document is valid for 4 years after the date of the signature.
Authorised Representative: TBC
SRN: TBC
DECLARATION
OF CONFORMITY
