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FDA 510(k)

Redermax 抗菌伤口基质

K号: K251582 · 2026-02-02

决定日期2026-02-02
产品代码FRO
决定实质等同

器械摘要

Redermax Antibacterial Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Kreate Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-02-02 under 510(k) number K251582. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Redermax Antibacterial Wound Matrix?

Redermax Antibacterial Wound Matrix is a medical device that received FDA 510(k) clearance on 2026-02-02. The listed applicant is Beijing Kreate Medical Co., Ltd.. The 510(k) number is K251582.

When did Redermax Antibacterial Wound Matrix receive FDA 510(k) clearance?

Redermax Antibacterial Wound Matrix received FDA 510(k) clearance on 2026-02-02, under 510(k) number K251582.

Who is the listed applicant for Redermax Antibacterial Wound Matrix?

FDA 510(k)记录将北京科瑞特医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Redermax Antibacterial Wound Matrix?

The FDA product code for Redermax Antibacterial Wound Matrix is FRO. This falls under the Anesthesiology category.

相关临床试验

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。

列明Beijing Kreate Medical Co., Ltd.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。

相关器械(代码:FRO)

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。

官方来源

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