FDA 510(k)

デウィン生殖メディア（デウィンゲートバッファー[HSA付きおよびHSAなし]; デウィン卵巣洗浄液、デウィンワンステップメディア[HSA付きおよびHSAなし])

K番号: K251637 · 2025-08-27

申請者Donnevie Medical Technology (Shanghai) Co. , Ltd.

決定日2025-08-27

製品コードMQL

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) 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 2025-08-27 under 510(k) number K251637. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])?

Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Donnevie Medical Technology (Shanghai) Co. , Ltd.. The 510(k) number is K251637.

When did Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) receive FDA 510(k) clearance?

Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) received FDA 510(k) clearance on 2025-08-27, under 510(k) number K251637.

Who is the listed applicant for Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])?

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 Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])?

The FDA product code for Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) is MQL.

申請者としてDonnevie Medical Technology (Shanghai) Co. , Ltd.を記載するその他の記録

K242561デウィン生殖メディア（デウィンビトライフィケーションキット、デウィン解凍キット）K231370デウィン・ blastocyst medium（HSA付きおよびHSAなし）K212426デウィン生殖メディア（デウィン精子濃縮液[HSA付きおよびHSAなし]およびデウィン分裂培地[HSA付きおよびHSAなし]）

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