Dewin 生殖培养基（Dewin 受精培养基[含HSA和不含HSA]和Dewin 裂解培养基[含HSA和不含HSA]）
K号: K212426 · 2022-06-16
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器械摘要
常见问题
What is the Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])?
Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Donnevie Medical Technology (Shanghai) Co. , Ltd.. The 510(k) number is K212426.
When did Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) receive FDA 510(k) clearance?
Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) received FDA 510(k) clearance on 2022-06-16, under 510(k) number K212426.
Who is the listed applicant for Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage 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 Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])?
The FDA product code for Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) is MQL.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Donnevie Medical Technology (Shanghai) Co. , Ltd.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：MQL）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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