FDA 510(k)

羅斯因膠原蛋白敷料

K 號：K253974 · 2026-06-03

決定日期2026-06-03

產品代碼KGN

決定相當於

器材摘要

Roosin Collagen Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Roosin Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K253974. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the Roosin Collagen Dressing?

Roosin Collagen Dressing is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Roosin Medical Co., Ltd.. The 510(k) number is K253974.

When did Roosin Collagen Dressing receive FDA 510(k) clearance?

Roosin Collagen Dressing received FDA 510(k) clearance on 2026-06-03, under 510(k) number K253974.

Who is the listed applicant for Roosin Collagen Dressing?

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

What is the FDA product code for Roosin Collagen Dressing?

The FDA product code for Roosin Collagen Dressing is KGN.

其他以 Roosin 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。

K254034羅斯因膠原粉 K231088銅泡沫敷料（處方藥和非處方藥）K230190多維爾銀鹼鹼敷料（處方藥和非處方藥）K181478羅斯因 Xeroform 煤焦油敷料

相關器械（代碼：KGN）

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。

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 外科維網，1cc（CG-01AP）；Accelagen Plus 外科維網，3cc（CG-03AP）；Accelagen Plus 外科維網，5cc（CG-05AP）；Accelagen Plus 外科條，125x25x2mm（CG-125X25AP）；Accelagen Plus 外科條，250x25x2mm（CG-250X25AP）Berkeley Advanced Biomaterials K260596膠原蛋白傷口粉末Ventris Medical K260669Endoform皮膚模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMD 医療設備規範文本翻譯： ECMT-100 WMD 医療設備規範文本Ecm Therapeutics, Inc.K253204催化BioTissue Holdings, Inc.

官方來源

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