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FDA 510(k)

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)

K-Number: K242089 · 2025-04-10

ApplicantJiangsu Ruifuda Medical Device Co., Ltd.
Decision Date2025-04-10
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) is a medical device manufactured by Jiangsu Ruifuda Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2025-04-10 under approval number K242089. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)?

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) is a medical device that received FDA 510(k) clearance on 2025-04-10. It is manufactured by Jiangsu Ruifuda Medical Device Co., Ltd.. The 510(k) number is K242089.

When was Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) approved by the FDA?

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) received FDA 510(k) clearance on 2025-04-10, under approval number K242089.

What company makes Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)?

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) is manufactured by Jiangsu Ruifuda Medical Device Co., Ltd..

What is the FDA product code for Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)?

The FDA product code for Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) is MQL.

Related Devices (Code: MQL)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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