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FDA 510(k)

Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)

K-Number: K242561 · 2025-04-10

ApplicantDonnevie Medical Technology (Shanghai) Co. , Ltd.
Decision Date2025-04-10
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) is a medical device manufactured by Donnevie Medical Technology (Shanghai) Co. , Ltd.. It received FDA 510(k) clearance on 2025-04-10 under approval number K242561. 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 Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)?

Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) is a medical device that received FDA 510(k) clearance on 2025-04-10. It is manufactured by Donnevie Medical Technology (Shanghai) Co. , Ltd.. The 510(k) number is K242561.

When was Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) approved by the FDA?

Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) received FDA 510(k) clearance on 2025-04-10, under approval number K242561.

What company makes Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)?

Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) is manufactured by Donnevie Medical Technology (Shanghai) Co. , Ltd..

What is the FDA product code for Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)?

The FDA product code for Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) is MQL.

Related Clinical Trials

NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

Other Devices by Donnevie Medical Technology (Shanghai) Co. , Ltd.

K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) K231370Dewin Blastocyst Medium (with HSA and without HSA) K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])

Related Devices (Code: MQL)

K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd. K153478Sydney IVF Gamete BufferWilliam A. Cook Australia Pty. , Ltd. K160863PBS(-), Phosphate Buffered SalineKitazato Biopharma Co., Ltd. K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitWilliam A. Cook Australia Pty. , Ltd. K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitWillian A. Cook Australia Pty, Ltd.

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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