MEDCHECK許可證索引
衛署醫器輸字
許可證編號008900
許可證編號008900
輸入器材
醫療器材許可證 ／ 輸入器材
"而至" 貼得適人造真皮
"GC" Terudermis Artificial Dermis
衛署醫器輸字第008900號
本站收錄狀態核准有效
有效日期2028 / 10 / 29
醫療器材級數第二等級
申請商為 台灣泰爾茂醫療產品股份有限公司，收錄 13 個 UDI 型號。 以下整理許可證、規格與製造廠資料，供核對產品身分使用。
許可證資料 依公開資料欄位整理
- 許可證字號
- 衛署醫器輸字第008900號
- 申請商
- 台灣泰爾茂醫療產品股份有限公司 （查看此申請商全部許可證）
- 統一編號
- 42820374
- 申請商地址
- 臺北市中正區忠孝西路1段4號8樓
- 發證日期
- 1998 / 10 / 29
- 有效日期
- 2028 / 10 / 29
- 限制項目
- 輸 入
- 資料異動日期
- 2023 / 09 / 15
這類器材是什麼 閉合用傷口/燒燙傷敷料，AI 輔助整理
閉合用傷口／燒燙傷敷料是蓋在傷口上、幫助傷口閉合與保護的醫療器材，從 OK 繃、人工皮到泡棉、矽膠敷料都算。在台灣屬於醫療器材，要確認包裝上的許可證字號。
跟一般紗布、OK 繃差在哪
這類敷料的重點是「閉合」——讓傷口保持在濕潤環境，幫助表皮修復，同時阻擋外來細菌。傳統紗布主要是吸收滲液、覆蓋保護，傷口乾掉時容易黏住，換藥時可能拉扯新生組織。OK 繃則是小面積、表淺傷口的簡便選擇。
常見的幾種敷料
品名裡常出現的關鍵字，可以幫你判斷用途：
- 透明敷料、防水護膜：薄、透明，常用來固定點滴或覆蓋小傷口，防水透氣。
- 泡棉敷料：較厚、吸滲液，適合有滲液的傷口。
- 矽膠敷料：表面有矽膠層，低沾黏，換藥時比較不痛。
- 膠原蛋白敷料、組織基質：屬於比較進階的傷口照護產品，通常由醫療人員評估後使用。
- 急救絆：就是一般 OK 繃類的小型敷料。
怎麼挑才對
- 看傷口大小、深淺和滲液量：滲液多選泡棉，表淺小傷口用透明敷料或 OK 繃。
- 看是否需要滅菌：本站收錄的型號幾乎都標示單次使用、滅菌包裝，開封後沒用完就不要再留。
- 看黏貼位置：關節、臉部等活動或敏感部位，可選低沾黏或矽膠材質。
- 不確定傷口該用哪一種，或傷口有感染跡象，交給醫療人員判斷。
怎麼確認買到合法的
包裝上要有醫療器材許可證字號，格式像「衛部醫器製字第○○○○○○號」，「製」是國內製造、「輸」是進口。本站收錄 94 張有效許可證，其中約 67% 是進口、33% 國內製造；等級以第 1 等級 63 張最多。字號可拿到本站查是否仍有效。
常見問題
人工皮就是這類敷料嗎？
算。人工皮通常指能保持傷口濕潤、幫助閉合的敷料，屬於這個分類。但「人工皮」是俗稱，實際產品可能是泡棉、水膠或薄膜材質，用途和更換時機不一樣，要看包裝標示。
敷料要每天換嗎？
不一定。要看滲液量和產品說明。滲液少、敷料還貼得住，可以依仿單建議的天數更換；滲液滲出敷料邊緣、或敷料鬆脫、有異味時就要換。太常換反而會干擾傷口癒合。
傷口貼著不透氣會爛掉嗎？
不會。這類敷料設計上多可防水透氣，能讓水氣散出、阻擋外面的水和細菌。真正要避免的是貼太久不換、或傷口已經感染還繼續悶著。
燒燙傷可以自己買敷料貼嗎？
小面積、表淺的燙傷可以先沖水降溫後用敷料覆蓋；面積大、起水泡、皮膚發白或變黑，或傷口在臉、關節等部位，請直接就醫，不要自行處理。
本段由 AI 依官方分類輔助整理，僅供認識器材之用，不構成醫療建議。使用前請以醫師指示與產品仿單為準。
UDI 標示 依 UDI 資料彙整
- 單次使用是
- 滅菌包裝未填
- 天然橡膠（乳膠）不含
- DEHP不含
- 批號有
- 序號無
- 製造日期有
- 有效期限有
- 健保特材未填
這張許可證底下有多個型號時，只要其中一款有標示，就顯示為「是」或「有」。
效能與規格
- 規格
- 2.5CM*2.5CM；2.5CM*5CM；5CM*5CM；10CM*CM 以下空白。詳如中文仿單核定本。新增提供電子化說明書之標籤-112.8.1。
製造廠
- 製造商
- GC Corporation Mishima Factory
- 國別
- 日本
- 廠址
- 454-1 HIGASHINO, NAGAIZUMI-CHO, SUNTO-GUN, SHIZUOKA 411-0931, JAPAN
- 製造許可登錄編號
- QSD17282
- 製造商
- GC CORPORATION
- 國別
- 日本
- 廠址
- 3-2-14 HONGO, BUNKYO-KU, TOKYO 113-0033 JAPAN
UDI 型號 共 13 筆
| 基本 DI | 型號 | 產品描述 | 單次使用 | 乳膠 | DEHP |
|---|---|---|---|---|---|
| 04550565001944 | TD*A006SJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565001951 | TD*A013SJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565001968 | TD*A025SJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565001975 | TD*A100SJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565001982 | TD*M006SJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565001999 | TD*M013SJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565002002 | TD*M025SJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565002019 | TD*M100SJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565002026 | TD*A006NJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565002033 | TD*A013NJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565002040 | TD*A025NJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565002057 | TD*A100NJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
| 04550565002064 | TD*A100SDJ | TERUDERMISTM is made of a low antigenic atelocollagen that is produced from a calf hide collagen eliminated the telopeptide by a preparation of protease. Due to treated by a preparation of thermal cross - linkage process, biocompatibility of the collagen itself is not compromised, a thus enabling TERUDERMISTM to reconstruct dermis-like tissue (granulo-like tissue) by the patient's own cells. | 是 | 否 | 否 |
找的不是這個型號？
可改用包裝上的完整型號或許可證字號查詢。