台灣醫療器材
許可證資料查詢
MEDCHECK許可證索引
衛部醫器陸輸字
許可證編號
001511
大陸輸入
醫療器材許可證 / 大陸輸入

"賽諾" 弘心通冠狀動脈球囊擴張導管

"SINO" SC HONKYTONK PTCA Balloon Dilatation Catheter

衛部醫器陸輸字第001511號
本站收錄狀態核准有效
有效日期2028 / 11 / 26
醫療器材級數第二等級

申請商為 科達健康生技股份有限公司,收錄 51 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
衛部醫器陸輸字第001511號
申請商
科達健康生技股份有限公司 (查看此申請商全部許可證)
統一編號
24320828
申請商地址
臺北市內湖區成功路4段188號9樓之25
發證日期
2023 / 11 / 26
有效日期
2028 / 11 / 26
限制項目
輸 入、中國貨品
資料異動日期
2024 / 02 / 20

這類器材是什麼 經皮穿刺冠狀動脈導管,AI 輔助整理

經皮穿刺冠狀動脈導管是心導管手術用的細長管子,從手腕或大腿的血管穿刺伸進冠狀動脈,用來撐開狹窄的血管、放支架或做檢查。這類器材由醫師操作,病人不會自己使用。

它跟一般導管差在哪

心導管檢查用的導管只是把顯影劑送到血管、量測壓力;這個分類下的導管多了氣球,可以擴張狹窄處。品名裡常見「球囊擴張導管」,就是氣球導管;「切割」「刻痕」「血管內碎石」是在氣球上加了刀片、線或震波功能,用來對付鈣化較硬的病灶;「藥物塗層」則是在氣球表面帶藥,撐開後把藥留在血管壁。這些差異由醫師依病灶狀況選擇。

誰會用到它

  • 檢查發現冠狀動脈有明顯狹窄,需要氣球擴張或放置支架的人。
  • 病灶鈣化嚴重,需要切割、刻痕或血管內碎石輔助的人。
  • 曾放過支架又再狹窄,醫師評估用藥物塗層氣球處理的人。
  • 急性心肌梗塞需要緊急打通血管的人。

怎麼確認合法

這類器材幾乎都是醫院採購、在導管室使用,病人不會在通路買到。本站收錄 115 張有效許可證,其中約 98% 是進口,國內製造只有 2 張;製造廠以中國、美國、荷蘭、瑞士較多。許可證字號格式像「衛部醫器輸字第○○○○○○號」,可上本站查是否仍有效。

使用前後要知道的事

  • 這類導管標示為單次使用、滅菌包裝,用過就丟,不會重複使用。
  • 術前通常要禁食、抽血檢查凝血功能與腎功能,並告知醫師藥物過敏史,尤其是顯影劑過敏。
  • 術後穿刺部位要加壓止血,依醫護指示休息,注意有沒有出血、腫脹或胸痛。
  • 氣球擴張後血管可能再狹窄,需要按時服藥與回診追蹤。

常見問題

冠狀動脈氣球擴張導管是什麼?

它是一根前端帶氣球的細導管,經由穿刺的血管送到冠狀動脈狹窄處,把氣球充氣撐開血管,恢復血流。必要時會接著放置支架。整個過程由心臟科醫師在導管室操作,病人是清醒或輕度鎮靜的狀態。

氣球擴張和放支架有什麼差別?

不一定哪個比較好。單純氣球擴張是把狹窄處撐開,但血管可能回彈或再狹窄;支架是放進金屬網狀支撐物把血管撐住,再狹窄率通常較低。選哪一種要看病灶位置、長度、鈣化程度和病人狀況,由醫師判斷。

藥物塗層氣球是什麼?

氣球表面塗有抑制血管內膜增生的藥物,充氣撐開時把藥留在血管壁,用來降低再狹窄。常用在支架內再狹窄或小血管病灶。是否適合使用,需由醫師依病灶評估。

手術後要注意什麼?

穿刺部位要依指示加壓與休息,當天避免劇烈活動;按時服用抗血小板等藥物,不要自行停藥;出現胸痛、呼吸困難、穿刺處大量出血或腫脹,盡快就醫。後續要定期回診追蹤。

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
  • 批號無
  • 序號有
  • 製造日期無
  • 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

效能
詳如核定之中文說明書
規格
詳如核定之中文說明書

製造廠

製造商
SINO Medical Sciences Technology Inc.
國別
中國
廠址
TEDA Biopharm Res. Building B and 4th Floor Building A, #5 4th St. TEDA, Tianjin China
製造許可登錄編號
QSD16798

UDI 型號 共 51 筆

此許可證底下的 UDI 型號
基本 DI型號產品描述單次使用乳膠DEHP
06948546214120SCB-2.25-15-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214137SCB-2.25-20-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214144SCB-2.25-25-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214151SCB-2.25-30-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214168SCB-2.25-35-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214175SCB-2.50-09-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214182SCB-2.50-12-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214199SCB-2.50-15-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214205SCB-2.50-20-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214212SCB-2.50-25-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214229SCB-2.50-30-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214236SCB-2.50-35-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214243SCB-2.75-09-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214250SCB-2.75-12-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214267SCB-2.75-15-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214274SCB-2.75-20-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214281SCB-2.75-25-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214298SCB-2.75-30-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214304SCB-2.75-35-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214311SCB-3.00-09-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214328SCB-3.00-12-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214335SCB-3.00-15-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214342SCB-3.00-20-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214359SCB-3.00-25-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214366SCB-3.00-30-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214373SCB-3.00-35-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214380SCB-3.50-09-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214397SCB-3.50-12-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214403SCB-3.50-15-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 是 否 否
06948546214410SCB-3.50-20-RXA rapid exchange catheter, including a semicompliance balloon close to the distal tip. The catheter’s distal portion is dual lumen and coaxial. 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。