FDA 510(k)

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

Numéro K : K242561 · 2025-04-10

DemandeurDonnevie Medical Technology (Shanghai) Co. , Ltd.

Date de décision2025-04-10

Code produitMQL

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) is the device name listed in this FDA 510(k) record. The listed applicant is Donnevie Medical Technology (Shanghai) Co. , Ltd.. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K242561. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Donnevie Medical Technology (Shanghai) Co. , Ltd.. The 510(k) number is K242561.

When did Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) receive FDA 510(k) clearance?

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

Who is the listed applicant for Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)?

The FDA 510(k) record lists Donnevie Medical Technology (Shanghai) Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Autres dossiers indiquant Donnevie Medical Technology (Shanghai) Co. , Ltd. en tant que demandeur

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

Dispositifs connexes (Code : MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato Corporation K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

Source officielle

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