510(k) K242089

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) by Jiangsu Ruifuda Medical Device Co., Ltd. — Product Code MQL

K242089 is an FDA 510(k) premarket notification submitted by Jiangsu Ruifuda Medical Device Co., Ltd. for the device "Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)". The FDA issued a decision of Substantially Equivalent on April 10, 2025. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180.