水溶性人體潤滑劑
K 號：K243107 · 2025-05-09
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決定日期2025-05-09
產品代碼NUC
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
Water Solubility Human Body Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Yanxuan Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K243107. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Water Solubility Human Body Lubricant?
Water Solubility Human Body Lubricant is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Dongguan Yanxuan Biotechnology Co., Ltd.. The 510(k) number is K243107.
When did Water Solubility Human Body Lubricant receive FDA 510(k) clearance?
Water Solubility Human Body Lubricant received FDA 510(k) clearance on 2025-05-09, under 510(k) number K243107.
Who is the listed applicant for Water Solubility Human Body Lubricant?
The FDA 510(k) record lists Dongguan Yanxuan Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Water Solubility Human Body Lubricant?
The FDA product code for Water Solubility Human Body Lubricant is NUC.
相關臨床試驗
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相關器械（代碼：NUC）
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。
K260117EverslideSpecial Situations, LLCK253989HARU Orgasm by jack herer 水基潤滑劑（WL-OJ）；HARU Orgasm 水基潤滑劑（WL-OR）；HARU STEAMY 水基潤滑劑（WL-ST）Maxigen Biotech, Inc.K261905BUM油Bumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP 水基個人潤滑劑及保濕劑PINKSLIP, LLCK261909Plum Vagiceuticals™ 阴道潤滑栓PCCA, Inc.K254011流動水性個人潤滑劑LBDO Group, Inc.
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。
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