FDA 510(k)

Dewin 生殖媒體（Dewin 液氮凍存組合包，Dewin 解凍組合包）

K 號：K242561 · 2025-04-10

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

決定日期2025-04-10

產品代碼MQL

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

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.

常見問題

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.

其他以 Donnevie Medical Technology (Shanghai) Co. , Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251637Dewin生殖培養基（Dewin配子緩衝液[含HSA和不含HSA]；Dewin卵泡沖洗液，Dewin一步培養基[含HSA和不含HSA]）K231370德文 blastocyst 中間培養基（含HSA與不含HSA）K212426Dewin 生殖媒質（Dewin 稔育媒質[含HSA與不含HSA]及Dewin 裂解媒質[含HSA與不含HSA]）

相關器械（代碼：MQL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254261凍結凈化組合包及融解組合包（CS-IVF-FK；CS-IVF-TK）CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248超快速加熱Kitazato Corporation K252672CaseBio™ 綠色培養液/含人血清白蛋白 (CMH5)；CaseBio™ 操控/含人血清白蛋白 (WHH5)Casebioscience, Inc.K250445快速加熱 - NXFujifilm Irvine Scientific K251637Dewin生殖培養基（Dewin配子緩衝液[含HSA和不含HSA]；Dewin卵泡沖洗液，Dewin一步培養基[含HSA和不含HSA]）Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305超快速玻化器；超快速加熱器Kitazato Corporation

官方來源

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