免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

FertiCult 清洗劑；含酚紅及壺菌素之 FertiCult 清洗劑

K 號：K242640 · 2025-05-30

申請人Fertipro NV
決定日期2025-05-30
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

FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin is the device name listed in this FDA 510(k) record. The listed applicant is Fertipro NV. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K242640. 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 FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin?

FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Fertipro NV. The 510(k) number is K242640.

When did FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin receive FDA 510(k) clearance?

FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin received FDA 510(k) clearance on 2025-05-30, under 510(k) number K242640.

Who is the listed applicant for FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin?

The FDA 510(k) record lists Fertipro NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin?

The FDA product code for FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin is MQL.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Fertipro NV 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。

K221547InActiv藍

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 CorporationK252672CaseBio™ 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 ScientificK251637Dewin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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑