FDA 510(k)

盧加設備

K 號：K250270 · 2025-04-17

決定日期2025-04-17

產品代碼EZD

諮詢委員會GU

決定相當於

器材摘要

Luja Set is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2025-04-17 under 510(k) number K250270. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Luja Set?

Luja Set is a medical device that received FDA 510(k) clearance on 2025-04-17. The listed applicant is Coloplast Corp.. The 510(k) number is K250270.

When did Luja Set receive FDA 510(k) clearance?

Luja Set received FDA 510(k) clearance on 2025-04-17, under 510(k) number K250270.

Who is the listed applicant for Luja Set?

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

What is the FDA product code for Luja Set?

The FDA product code for Luja Set is EZD.

其他以 Coloplast Corp. 為申請人之記錄

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相關器械（代碼：EZD）

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。

K261418Liquick X-treme, Liquick X-treme PlusTeleflex Medical K260737Cure Aqua™ 即用型親水性間歇性導尿管女性用 (CH06 - CH16)；Cure Aqua™ 即用型親水性間歇性導尿管男性直型 (CH06 - CH18)；Cure Aqua™ 即用型親水性間歇性導尿管男性彎型 (CH10 - CH18)。Convatec K261658LoFric Origo Pro CoudéWellspect AB K262045盧加軟件Coloplast A.S.K260394親水性塗層單次使用間歇性奈頓導尿管（NCR）Hangzhou Jimushi Meditech Co., Ltd.K253295曲管套筒內芯IC；曲管加套筒內芯ICHollister Incorporated

官方來源

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