MEDCHECK許可證索引

衛部醫器輸字
許可證編號030615

輸入器材

醫療器材許可證／輸入器材

“博士倫”雙極電燒探頭及雙極電燒鑷

“Bausch + Lomb” Bipolar Eraser and Bipolar Forceps

衛部醫器輸字第030615號

本站收錄狀態核准有效

有效日期2027 / 12 / 14

醫療器材級數第二等級

申請商為 博士倫股份有限公司，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030615號
申請商: 博士倫股份有限公司（查看此申請商全部許可證）
統一編號: 20921588
申請商地址: 臺北市大安區敦化南路2段95號29樓
發證日期: 2017 / 12 / 14
有效日期: 2027 / 12 / 14
限制項目: 輸入
資料異動日期: 2024 / 04 / 02

這類器材是什麼射頻電燒灼器具，AI 輔助整理

射頻電燒器具是用高頻電流來止血或切割組織的器械，眼科這一類多半是雙極電燒的探頭、鑷子、電線，搭配手術使用。它屬於醫療器材，由醫師在開刀房操作，不是民眾自己買來用的東西。

它到底在手術裡做什麼

眼科手術視野小、出血會擋住視線，這類器械用高頻電流讓組織局部凝固，達到止血或切開的效果。雙極的意思是電流在兩個尖端之間流動，作用範圍比較集中，對周邊組織的影響較小，所以常用在眼睛這種精細的部位。

為什麼常看到「配件」兩個字

這個分類的許可證只有 6 張，其中好幾張的品名是電線、探頭、鑷子這類配件。原因是主機和配件可能分屬不同許可證，手術時要整組搭配使用。

雙極電線：把主機的能量接到器械的連接線。
雙極電燒探頭、電燒鑷：實際接觸組織、執行止血或切割的部分。
囊袋切割系統及配件：配合白內障手術使用的切割工具。
晶體乳化儀配件：搭配超音波乳化主機使用的周邊器械。

誰會用到它

只有執行手術的醫師和手術室團隊會操作，民眾不會在一般通路接觸到。你比較可能遇到的是手術前被說明會使用這類器械，或術後在收費明細上看到名稱。

和一般電燒刀差在哪

單極電燒的電流要經過病人身體再從貼在身上的迴路電極流回，作用範圍較大；雙極電燒只在器械兩個尖端之間流動，不需要體表迴路電極，對鄰近組織的熱傷害較小。眼科手術講究精細，所以偏向用雙極。

常見問題

射頻電燒器具可以自己買嗎？

不行。這類器械是手術用醫療器材，由醫療院所採購、醫師操作，一般民眾買不到，也不該自行使用。網路上如果看到有人在賣，反而要懷疑來源是否合法。

電燒止血會不會很痛？

手術中通常不會。這類手術多在麻醉下進行，病人不會感覺到電燒的當下反應。術後的不適主要來自傷口本身，和有沒有用電燒的關係不大，實際狀況依手術方式而定。

怎麼知道醫院用的是合法器材？

可以看器材包裝或標籤上的醫療器材許可證字號，格式像「衛部醫器輸字第○○○○○○號」。本站收錄的 6 張射頻電燒器具許可證全部是進口，製造廠以美國最多。有疑慮可在術前向醫療團隊詢問。

這種器械可以重複使用嗎？

看產品標示。本站收錄的 40 筆型號中，約 60% 標示為單次使用，也就是用完就丟；其餘是否可重複使用、怎麼清潔滅菌，要依原廠仿單和醫院規定，不能自行判斷。

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

單次使用否
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

效能: 詳如中文仿單核定本
規格: 詳如中文仿單核定本

製造廠

製造商: Bausch & Lomb GmbH
國別: 德國
廠址: Lilienthalstraße 16, 18 69214 Eppelheim Germany
製程: 全部製程
製造許可登錄編號: QSD16884

UDI 型號共 12 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
04058935000530	E7924	The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size.	否	否	否
04058935000547	E7925	The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size.	否	否	否
04058935000554	E7926	The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size.	否	否	否
04058935000561	E7927	The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size.	否	否	否
04058935000578	E7928	The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size.	否	否	否
04058935000585	E7929	The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size.	否	否	否
04058935000592	E7930	The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size.	否	否	否
04058935000608	E7931	The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size.	否	否	否
04058935000660	E7920	The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size.	否	否	否
04058935010089	D8200	Bipolar Forceps provide an isolated electrical output with negligible leakage of current between the poles of the instrument, permitting use of coagulation current in proximity to structures where ordinary unipolar coagulation would be undesirable. The affected tissue or vessel is pinched between the two forceps tips allowing the high frequency current to pass from one tip of the forceps, through the tissue to the second tip, causing coagulation. The Bipolar Instruments require a cord to provide the connection between the electrical device and the Bipolar Instruments. Device with Lemosa-type connector is used with reusable Bipolar Cord CX9430.	否	否	否
04058935010096	D8201	The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size.	否	否	否
04058935010102	D8203	The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size.	否	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。