FDA 510(k)

Luja软性产品

K号: K262045 · 2026-07-07

决定日期2026-07-07

产品代码EZD

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决定实质等同

器械摘要

Luja Soft is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A.S.. It received FDA 510(k) clearance on 2026-07-07 under 510(k) number K262045. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Luja Soft?

Luja Soft is a medical device that received FDA 510(k) clearance on 2026-07-07. The listed applicant is Coloplast A.S.. The 510(k) number is K262045.

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

Luja Soft received FDA 510(k) clearance on 2026-07-07, under 510(k) number K262045.

Who is the listed applicant for Luja Soft?

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

What is the FDA product code for Luja Soft?

The FDA product code for Luja Soft is EZD.

列明Coloplast A.S.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。

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相关器械（代码：EZD）

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。

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