MEDCHECK許可證索引
衛部醫器輸字
許可證編號038038
許可證編號038038
輸入器材
醫療器材許可證 ／ 輸入器材
“飛利浦” 心電圖儀
“Philips” Cardiac Workstation
衛部醫器輸字第038038號
本站收錄狀態核准有效
有效日期2030 / 05 / 26
醫療器材級數第二等級
申請商為 台灣飛利浦股份有限公司，收錄 20 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038038號
- 申請商
- 台灣飛利浦股份有限公司 （查看此申請商全部許可證）
- 統一編號
- 11916803
- 申請商地址
- 臺北市信義區市民大道6段288號10樓之6
- 發證日期
- 2025 / 05 / 26
- 有效日期
- 2030 / 05 / 26
- 限制項目
- 輸 入
- 資料異動日期
- 2025 / 06 / 11
這類器材是什麼 心電圖描記器，AI 輔助整理
心電圖描記器就是記錄心臟電氣活動的機器，把貼在身上的電極收到的訊號畫成波形，用來檢查心律和心跳。在台灣它是醫療器材，從醫院的大型機器到居家單導程小機都算。
醫院用和居家用差在哪
同樣叫心電圖機，差別在導程數量和用途。醫院做的是 12 導程，電極貼在四肢和胸前共十個位置，一次記錄心臟各角度的電氣活動，由醫師判讀。居家機種多半是單導程或少量導程，只能看到一個方向的訊號，方便隨時記錄，但不能取代 12 導程檢查。
- 12 導程：診斷用，通常在醫療院所由技術人員操作。
- 單導程／手持式：居家記錄用，適合有心悸、胸悶等症狀時按一下記錄。
- 連續監測型：貼在身上記錄一整天或更久，抓陣發性的心律不整。
誰會用到它
- 有心悸、胸悶、頭暈、昏厥等症狀，醫師懷疑心律問題的人。
- 已知有心律不整、正在追蹤或調藥的人。
- 手術前評估、健檢或心血管風險評估。
- 居家監測族群，例如症狀發作時間短、到醫院時已經正常的人。
怎麼挑居家機種
先看用途。如果只是偶爾心悸想留紀錄給醫師看，單導程機種就夠；如果醫師要求長時間監測，要用能連續記錄的機型。買之前確認包裝或說明書上有醫療器材許可證字號，並確認記錄下來的資料要怎麼交給醫師判讀，有些機種搭配手機 App 或雲端服務。
買的時候怎麼確認合法
包裝或說明書上要有許可證字號，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 121 張有效許可證，國內製造約四成，進口以美國、日本、中國較多。拿到字號可以直接在本站查是否仍有效。
常見問題
心電圖機可以自己買回家用嗎？
可以，居家型心電圖機是合法的醫療器材，買得到。但它記錄的是訊號，判讀還是要交給醫師。自己看波形容易誤判，記錄到異常時應該把資料帶去門診。
居家心電圖機測出來的結果準嗎？
不一定，要看機型和用法。單導程機種只記錄一個方向，對某些心律問題敏感度有限。電極位置貼錯、皮膚太乾或太油、身體晃動，都會影響訊號品質。它的價值在於症狀發作當下能留下紀錄。
心電圖機和血壓計有什麼差別？
兩者量的是不同東西。血壓計量的是血管裡的壓力，心電圖機記錄的是心臟的電氣活動。有些機型把兩者做在一起，但功能各自獨立，不能互相取代。
戴心律監測器可以洗澡嗎？
不一定，要看機型。有些連續監測裝置的電極和主機不能碰水，洗澡時要取下；有些標示防水可以戴著沖洗。實際能不能碰水、能不能戴著睡，依產品說明書和醫療人員的指示。
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
- 滅菌包裝否
- 天然橡膠（乳膠）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
- 詳如核定之中文說明書
- 規格
- Cardiac Workstation 5000、Cardiac Workstation 7000。
【成分、材料、結構、規格或型號】及【效能、用途或適應症變更】，詳如核定之【標籤、說明書或包裝】（原114年6月11日核定之【標籤、說明書或包裝】予以回收作廢）。
以下空白
製造廠
- 製造商
- Philips Medizin Systeme Böblingen GmbH
- 國別
- 德國
- 廠址
- Hewlett-Packard-Straβe 2, 71034 Böblingen, Germany
- 製造商
- Philips North America LLC
- 國別
- 美國
- 廠址
- 1001 Murry Ridge Lane, STE A, Murrysville, PA 15668, USA
- 製程
- 全部製程
- 製造許可登錄編號
- QSD15752
UDI 型號 共 20 筆
| 基本 DI | 型號 | 產品描述 | 單次使用 | 乳膠 | DEHP |
|---|---|---|---|---|---|
| 20884838006991 | 40420A | HI-Tack Foam Wet Gel ECG Electrode | 是 | 否 | 否 |
| 20884838086832 | 989803166031 | Clear Tab/Snap Adapter 10/bag | 否 | 否 | 否 |
| 00840828183840 | 989803209691 | Clear Tab/Snap Adapter | 否 | 否 | 否 |
| 00884838094826 | 860439 | Cardiac Workstation 5000 | 否 | 否 | 否 |
| 00884838117235 | 989803151671 | Chest lead Set for PageWriter TC Series Cardiographs AAMI and IEC color coded, consisting of one 1 in 3 (Trident) Lead ( 28" (70 cm)), 12*2 colored rings, 3 brown base rings, 3 white base rings (both AAMI and IEC), 3 banana post adapters, 4 Trident Yoke lead description lables (V1-V3, V4-V6, C1-C3, C4-C6) and instruction for use. The Trident lead comes assembled with the lead separator. | 否 | 否 | 否 |
| 00884838117273 | 989803151751 | Upgrade Kit 12-15/16 leads AAMI color coded for PageWriter TC 70. Consisting of 4 additional lead assy (33" (0,84m)), 6 shorting plugs, 2 lead separators, 6 colored clips, 6 colored rings, 4 brown base rings and instructions for use. 1 kit = 1 sales unit. | 否 | 是 | 否 |
| 00884838117280 | 989803151761 | Upgrade Kit 12-15/16 leads IECI color coded for PageWriter TC 70. Consisting of 4 additional lead assy (33", (0,84m)), 6 shorting plugs, 2 lead separators, 4 banana post adapters, 6 colored clips, 6 colored rings, 4 white base rings and instructions for use. The additional lead sets come pre-assembled with the 4 white base rings and the banana post adapter. 1 kit = 1 sales unit. | 否 | 是 | 否 |
| 00884838117297 | 989803151771 | Long Upgrade Kit 12-15/16 leads AAMI color coded for PageWriter TC70. Consisting of 4 additional long lead assy (48", 1,22m)), 6 shorting plugs, lead separators, 6 colored clips, 6 colored rings, 4 brown base rings and instructions for use. The additional lead sets come pre-assembled with the brown base rings. 1 kit = 1 sales unit. | 否 | 是 | 否 |
| 00884838117303 | 989803151781 | Long Upgrade Kit 12-15/16 leads IEC color coded for PageWriter TC70. Consisting of 4 additional long lead assy (48" (1,22m)), 6 shorting plugs, 2 lead separators 3.4 DIA, 4 banana post adapters, 6 colored clips, 6 colored rings, 4 white base rings and instructions for use.The long additions lead sets come pre-assembled with the white base ring and the banana post adapters. 1 kit = 1 sales unit. | 否 | 是 | 否 |
| 00884838013162 | 40494E (989803101691) | Electrode,limb clamp Icon/C400 4/bx | 否 | 是 | 否 |
| 00884838094833 | 860441 | Cardiac Workstation 7000 | 否 | 否 | 否 |
| 00884838117198 | 989803151631 | Complete Lead Set for PageWriter TC Series Cardiographs, AAMI Color Coded. Consisting of 2 arm leads (39"(1m)), 2 leg leads (41" (1,04m)), and 2x 1 into 3 Trident leads (28" (70 cm)), 2 lead separators 2.54 DIA, 2 Trident Yoke labels (V1-V3,V4-V6), 4 colored clips, 14 colored rings, 6 brown base rings and instructions for use.This lead set comes fully assembled. 1 complete lead set = 1 sales unit | 否 | 是 | 否 |
| 00884838117204 | 989803151641 | Complete Lead Set for PageWriter TC Series Cardiographs, IEC Color Coded. Consisting of 2 arm leads (39"(1m)), 2 leg leads (41" (1,04m)), and 2x 1 into 3 Trident leads (28" (70cm)), 2 lead separators 2.54 DIA, 2 banana post adapters, 2 Trident Yoke labels (C1-C3,C4-C6), 4 colored clips, 14 colored rings, 6 white base rings and instructions for use. This lead set comes fully assembled. 1complete lead set = 1 sales units | 否 | 是 | 否 |
| 00884838117211 | 989803151651 | Long complete lead set for PageWriter TC Series Cardiographs, AAMI color coded. Consisting of 2 long arm leads (54" (1,37m)), 2 long leg leads (56" (1,42m)), 2 long 1 into 3 Trident leads (42" (1,07m)), 2 lead separators, 2.54 DIA, 2 Trident Yoke labels (V1-V3, V4-V6), 4 colered clips, 14x colored rings, 6 brown base rings and instructions for use. This lead set comes fully assembled. 1complete lead set = 1 sales unit | 否 | 是 | 否 |
| 00884838117228 | 989803151661 | Long complete lead set for PageWriter TC Series Cardiographs, IEC color coded. Consisting of 2 long arm leads (54" (1,37m)), 2 long leg leads (56" (1,42m)), 2 long 1 into 3 Trident leads ( 42"(1,07m)), 2 lead separators, 2.54 DIA, 10 banana post adapters, 2 Trident Yoke labels (C1-C3, C4-C6), 4 colored clips, 14x colored rings, 6 white base rings and instructions for use. This lead set comes fully assembled. 1 complete lead set = 1 sales unit | 否 | 是 | 否 |
| 00884838117242 | 989803151691 | Long Chest lead Set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of one long 1 in 3 (Trident) Lead (42" (1,07m)), 13*2 colored rings, 3 brown base rings, 3 white base rings (both AAMI and IEC), 3 banana post adapters, 1 lead separatorr 2.54 DIA, 4 Trident Yoke lead description lables (V1-V3, V4-V6, C1-C3, C4-C6) and instructions for use. The Trident lead comes assembled with the lead separator. | 否 | 否 | 否 |
| 00884838117259 | 989803151711 | Limb lead set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of 2 arm leads (39",99cm), 2 leg leads (41", 1,04m), 5*2 colored rings and 13*2 colored clips for AAMI and IEC, 4 banana post adapters and instructions for use. No clips or rings pre-assembled. 1 complete lead set = 1 sales unit | 否 | 是 | 否 |
| 00884838117266 | 989803151731 | Long Limb lead set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of 2 long arm leads (54",1,37m), 2 long leg leads (56", 1,42m), 13*2 colored rings and 5*2 colored clips for AAMI and IEC, 4 banana post adapters and instructions for use. No clips pre-assembled | 否 | 是 | 否 |
| 10884838046747 | 989803185251 | Reusable welsh bulb electrode, AHA/IEC | 否 | 否 | 否 |
| 20884838116225 | 40420A | HI-Tack Foam Wet Gel ECG Electrode | 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。