FDA 510(k)

Redermax 抗菌傷口維網

K 號：K251582 · 2026-02-02

決定日期2026-02-02

產品代碼FRO

決定相當於

器材摘要

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.

常見問題

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) 記錄將北京創科醫療有限公司列為申請人。這並不單獨確立設備製造商的身份。

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.

其他以 Beijing Kreate Medical 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。

K261646Redermax® 抗菌傷口組織 K260020Redermo 瘘傷組織

相關器械（代碼：FRO）

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。

K254168Actolind® (06.3637. Actolind®膠漿)ACTO GmbH K254041皮膚智選抗菌濕凝膠Magic Science Supply, LLC K261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLC K251929SilverCeuticals® 抗菌傷口膠Silverceuticals, Inc.K261023微達辛傷口灌洗溶液Sonoma Pharmaceuticals, Inc.

官方來源

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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。