Instructions for Use
Regulatory documentation for ReSpindle, a Class I medical device per Regulation (EU) 2017/745.
ReSpindle is an AI-powered decision support software intended to assist qualified embryologists with spindle morphology scoring of oocytes during ICSI procedures. It is not intended for autonomous clinical decision-making.
Classification: Annex VIII, Chapter III, Section 6.3, Rule 11.
Manufacturer: Gamow Tech B.V., Oxfordlaan 55, 6229EV Maastricht, The Netherlands.
SRN: NL-MF-000052511.
The device shall be used only by trained laboratory personnel in accordance with the instructions provided below.
Device label — ReSpindle Version 1.1