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FDA 510(k)

無香月經長型置入器衛生棉條；無香月經紙盒置入器衛生棉條；無香月經數位衛生棉條

K 號：K253719 · 2025-12-17

申請人Unibeauty (Hubei) Technology Co., Ltd.
決定日期2025-12-17
產品代碼HEB
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

Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons is the device name listed in this FDA 510(k) record. The listed applicant is Unibeauty (Hubei) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-17 under 510(k) number K253719. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons?

Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons is a medical device that received FDA 510(k) clearance on 2025-12-17. The listed applicant is Unibeauty (Hubei) Technology Co., Ltd.. The 510(k) number is K253719.

When did Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons receive FDA 510(k) clearance?

Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons received FDA 510(k) clearance on 2025-12-17, under 510(k) number K253719.

Who is the listed applicant for Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons?

The FDA 510(k) record lists Unibeauty (Hubei) Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons?

The FDA product code for Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons is HEB.

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 Unibeauty (Hubei) Technology 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。

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相關器械（代碼：HEB）

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。

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官方來源

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