許可證編號036845
“醫學微型儀器”顯微手術輔助系統
“MMI” SYMANI surgical system
申請商為 超微醫學科技股份有限公司,收錄 12 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
- 衛部醫器輸字第036845號
- 申請商
- 超微醫學科技股份有限公司 (查看此申請商全部許可證)
- 統一編號
- 96754131
- 申請商地址
- 高雄市鼓山區明華路253號6樓
- 發證日期
- 2024 / 05 / 08
- 有效日期
- 2029 / 05 / 08
- 限制項目
- 輸 入
- 資料異動日期
- 2026 / 02 / 12
這類器材是什麼 其他,AI 輔助整理
這個分類是「其他」,收的是整形外科、皮膚科用、但歸不進其他細項的醫療器材,像是皮下填補劑、敷料、義乳推進器、皮膚鏡、光動力雷射等。
這類器材大概有哪些
從品名看,內容很雜,共同點是跟皮膚、皮下組織或整形手術相關。實際買到什麼、怎麼用,要看個別許可證的核准內容,不能只看分類名稱。
- 注射類:皮下填補劑、植入劑,例如聚左旋乳酸這類成分。
- 傷口與皮膚用:凝膠敷料、各類敷料。
- 手術輔助:義乳推進器、組織分離與均質化設備。
- 診斷與治療設備:皮膚鏡、光動力雷射。
和一般保養品差在哪
差在它是醫療器材,不是化妝品。以皮下填補劑來說,施打屬於醫療行為,要由醫師執行;敷料若標示滅菌,通常用在有傷口或術後的皮膚,跟一般保濕乳液不一樣。皮膚鏡、雷射這類設備則是醫療院所使用。
怎麼確認買到的是合法的
包裝或說明書上要有醫療器材許可證字號,格式像「衛部醫器輸字第○○○○○○號」或「衛部醫器製字第○○○○○○號」。這個分類的 76 張有效許可證裡,進口占多數,美國、韓國、台灣、英國是主要製造地。字號可以拿到本站查是否還有效。
使用的時候要注意什麼
- 注射類產品只能由醫師施打,不要接受來源不明、當場推銷的針劑。
- 標示滅菌的敷料,開封後依仿單使用,不要放到過期。
- 雷射、皮膚鏡等設備屬醫療行為,由醫療人員操作。
- 使用後出現紅腫、疼痛、發燒等異常,盡快回診。
常見問題
皮下填補劑是醫療器材嗎?
是。這類注射進皮下的填補劑在台灣以醫療器材管理,要有許可證才能輸入或製造。施打屬醫療行為,須由醫師評估與執行,不能自己買來打。
這個分類的器材可以自己買回家用嗎?
不一定。敷料、皮膚鏡這類有些可在通路買到,注射類填補劑、義乳推進器、雷射設備則屬醫療院所使用。購買前看仿單標示的用途與使用對象,不確定的先問醫師。
包裝上沒看到許可證字號怎麼辦?
先不要用。合法輸入或製造的醫療器材,包裝上會標示許可證字號、品名、製造廠與有效期間。沒有字號或字號查不到,可能是未經核准的產品,可向當地衛生局反映。
敷料和一般OK繃一樣嗎?
不完全一樣。一般OK繃多屬低風險品項,這個分類裡的凝膠敷料、滅菌敷料,部分屬於第2、第3等級,用在傷口或術後皮膚,用途與適用情況要看仿單,嚴重的傷口請就醫處理。
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
- 滅菌包裝是
- 天然橡膠(乳膠)不含
- DEHP不含
- 批號有
- 序號有
- 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
- 效能
- 本產品用於執行顯微外科技術的軟組織操作,如血管、神經和淋巴管等小解剖結構開放性手術的吻合、縫合和結紮。
- 規格
- 詳如核定之中文說明書。
標籤、說明書或包裝變更、增加規格及規格變更:詳如核定之標籤、說明書或包裝(原113年5月24日核定之標籤、說明書或包裝予以回收作廢)-115.2.11。
標籤、說明書或包裝變更:詳如核定之標籤、說明書或包裝(115年2月11日核定之標籤、說明書或包裝予以回收作廢)-115.4.20。
製造廠
- 製造商
- Medical Microinstruments, Inc.
- 國別
- 義大利
- 廠址
- Via Egidio Giannessi, 52-54-56, 56121 Pisa, Italy
- 製程
- 全部製程
- 製造許可登錄編號
- QSD14386
UDI 型號 共 12 筆
| 基本 DI | 型號 | 產品描述 | 單次使用 | 乳膠 | DEHP |
|---|---|---|---|---|---|
| 06975085705949 | DRP-302A | Robot Drape | 是 | 否 | 否 |
| 06975085705970 | DRP-201 | Master Drape | 是 | 否 | 否 |
| 07467423230149 | DRP-100 | CHAIR DRAPE (DRP-100-DO) | 是 | 否 | 否 |
| 08055713170146 | CMM-B010 | An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities. | 否 | 否 | 否 |
| 08055713170504 | CNS-100 | An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities. | 否 | 否 | 否 |
| 08055713171037 | INS-AeT1221 | A surgical device intended to be used in conjunction with a robotic surgical system, to grasp a suture needle when pushing/pulling the needle and attached suture through tissue for suturing during a robotic endoscopic (e.g., laparoscopic) procedure. It has a long slender shaft with a distal forceps-like gripping mechanism and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a single-use device. | 是 | 否 | 否 |
| 08055713171044 | INS-ObM1221 | A surgical device intended to be used in conjunction with a robotic surgical system to grasp tissue (typically atraumatically) or foreign bodies during a robotic endoscopic procedure. It is designed as a long shaft with a pair of scissors-like grasping tongs or claws at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system; it is not an electrosurgical instrument. This is a single-use device. | 是 | 否 | 否 |
| 08055713171051 | INS-NaS2221 | A surgical device intended to be used in conjunction with a robotic surgical system, to grasp a suture needle when pushing/pulling the needle and attached suture through tissue for suturing during a robotic endoscopic (e.g., laparoscopic) procedure. It has a long slender shaft with a distal forceps-like gripping mechanism and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a single-use device. | 是 | 否 | 否 |
| 08055713171068 | INS-DbS1221 | A surgical device intended to be used in conjunction with a robotic surgical system to grasp tissue (typically atraumatically) or foreign bodies during a robotic endoscopic procedure. It is designed as a long shaft with a pair of scissors-like grasping tongs or claws at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system; it is not an electrosurgical instrument. This is a single-use device. | 是 | 否 | 否 |
| 08055713171075 | INS-NeS1221 | A surgical device intended to be used in conjunction with a robotic surgical system, to grasp a suture needle when pushing/pulling the needle and attached suture through tissue for suturing during a robotic endoscopic (e.g., laparoscopic) procedure. It has a long slender shaft with a distal forceps-like gripping mechanism and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a single-use device. | 是 | 否 | 否 |
| 08055713175004 | ACC-101 | An adaptor intended to function as a connecting interface between a robotic surgical system articulated arm and an attached surgical instrument. This is a single-use device. | 是 | 否 | 否 |
| 08055713175028 | ACC-220 | A device designed to be used to transiently hold sections of drape together or to a medical device/equipment during a surgical procedure. It is typically in the form of a curved blade or two joined blades. This is a single-use device. | 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。