FDA 510(k)

MatriDerm pluS+雙層

K 號：K250864 · 2025-12-19

決定日期2025-12-19

產品代碼KGN

決定相當於

器材摘要

MatriDerm pluS+ Bi-Layer is the device name listed in this FDA 510(k) record. The listed applicant is Medskin Solutions Dr. Suwelack AG. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K250864. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the MatriDerm pluS+ Bi-Layer?

MatriDerm pluS+ Bi-Layer is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Medskin Solutions Dr. Suwelack AG. The 510(k) number is K250864.

When did MatriDerm pluS+ Bi-Layer receive FDA 510(k) clearance?

MatriDerm pluS+ Bi-Layer received FDA 510(k) clearance on 2025-12-19, under 510(k) number K250864.

Who is the listed applicant for MatriDerm pluS+ Bi-Layer?

The FDA 510(k) record lists Medskin Solutions Dr. Suwelack AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MatriDerm pluS+ Bi-Layer?

The FDA product code for MatriDerm pluS+ Bi-Layer is KGN.

其他以 Medskin Solutions Dr. Suwelack AG 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。

K261224MatriDerm K201577MatriDerm

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。

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官方來源

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