MEDCHECK許可證索引

衛部醫器輸壹字
許可證編號020575

輸入器材

醫療器材許可證／輸入器材

"康樂保"善舒樂密優造口術用袋及其附件(未滅菌)

"Coloplast" SenSura Mio Ostomy Pouch and Accessories (Non-Sterile)

衛部醫器輸壹字第020575號

本站收錄狀態核准有效

有效日期2029 / 06 / 21

醫療器材級數第一等級

申請商為 康樂保股份有限公司，收錄 24 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: 衛部醫器輸壹字第020575號
申請商: 康樂保股份有限公司（查看此申請商全部許可證）
統一編號: 42866379
申請商地址: 臺北市松山區民生東路3段129號6樓
發證日期: 2019 / 06 / 21
有效日期: 2029 / 06 / 21
限制項目: 輸入
資料異動日期: 2024 / 02 / 23

這類器材是什麼造口術用袋及其附件，AI 輔助整理

造口術用袋就是俗稱的「造口袋」，用來收集腸道或泌尿道造口排出的糞便、尿液。它靠底盤黏在造口周圍的皮膚上，袋子可更換或清空，是造口人每天都要用的醫療器材。

單片式、兩片式差在哪

差別在袋子和底盤是不是連在一起。本站收錄的 71 張許可證裡，進口占了 64 張，國內製造只有 7 張。

單片式：底盤和袋子一體成型，貼上後整組一起換，步驟少、體積較薄，適合剛手術後或手部動作較不靈活的人。
兩片式：底盤先貼在皮膚上，袋子再扣上去，底盤可留幾天、袋子隨時換或清空，皮膚較少被反覆撕貼。
一件式閉口袋：裝滿就整袋丟棄，適合糞便較成形的人。
一件式開口袋：底部可打開倒出內容物，可重複清空再使用。

附件在做什麼

造口袋要貼得牢，靠的是底盤和皮膚之間的密合。附件就是補強這件事，常見的有造口膠帶、皮膚保護膜、除膠劑、彈性環、防漏膏等。它們的用途不同，不是每一種都適合每個人，通常由造口護理師依造口形狀、位置和皮膚狀況建議搭配。

怎麼挑才貼得住

看造口大小和高度：底盤的開口要配合造口直徑，太大容易滲漏，太小會壓迫造口。
看造口形狀：圓形、橢圓形或不規則，有些產品可自行裁剪。
看皮膚狀況：皮膚有凹陷、皺褶或曾經破皮，可能需要防漏膏或皮膚保護膜補平。
看排泄物性質：稀水便比成形便更容易滲漏，底盤更換頻率通常也不同。
看生活型態：活動量大、常游泳或運動的人，會偏好較薄、較服貼的款式。

買的時候怎麼確認合法

包裝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」。本站收錄的 71 張都屬第 1 等級，風險相對低，但仍是列管醫材，沒有字號的來源不要買。字號可拿到本站查是否仍有效。

常見問題

造口袋多久要換一次？

不一定，要看款式和個人狀況。兩片式的底盤通常可留數天，袋子則每天或裝到約三分之一至一半時清空更換；單片式整組一起換。實際頻率依造口種類、排泄物性質和皮膚耐受度而定，可請造口護理師協助調整。

造口袋可以重複使用嗎？

不行。本站收錄的型號中約 95% 標示為單次使用，袋子裝過排泄物後清潔不易，重複使用會增加感染和皮膚問題。開口袋可以清空後繼續使用，但整組仍要按建議週期更換。

造口周圍皮膚紅癢怎麼辦？

先別硬貼。紅癢常見原因是滲漏刺激或撕除時拉扯皮膚。先取下袋子，用溫水清潔、拍乾，讓皮膚休息，確認底盤開口尺寸是否合適。若破皮、起水泡或有分泌物，請就醫或找造口護理師處理。

造口袋有分滅菌和未滅菌，差在哪？

差在出廠時有沒有經過滅菌處理。本站收錄的型號中，標示滅菌包裝的只有約 2%，其餘多為未滅菌。一般居家使用的造口袋多為未滅菌，手術後初期或特殊情況要用哪一種，依醫療人員指示。

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）不含
DEHP不含
批號有
序號無
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: 限醫療器材分類分級管理辦法「造口術用袋及其附件(H.5900)」第一等級鑑別範圍。

製造廠

製造商: COLOPLAST HUNGARY KFT
國別: 匈牙利
廠址: KEREK UTCA 4, 2800 TATABANYA, HUNGARY

UDI 型號共 24 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
05701780178778	10502	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780178792	10512	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780178815	10522	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780178839	10531	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780178914	16901	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780178938	16911	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780178952	16921	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780178976	16931	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780178990	16941	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780179010	16951	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780179034	16961	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780179058	16971	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile). Indication：Ostomy plate and bag are mainly used to collect the output from stoma. Ostomy plate will stick on the skin surround the stoma in order to bind with ostomy bag. Ostomy bag will be used to collect the output from the stoma. Method of Use： How to stick on - One-piece bag or ostomy plate ~ Cut the hole based on the size of the stoma，then peel off the protection sheet on the back of plat，then stick the one-piece bag or ostomy plate on the skin surround the stoma。Use the finger to press from bottom to top of the plate and let the plate stick on the skin firmly。 - Two-piece bag ~ Click the bag onto the buckle of the plate and use index finger and thumb to close the lock。 How to empty the uro bag - Hold the bag upside by gripping the end of open，press on the top of outlet，pull out the stopper and release the top of the outlet，and empty the bag。 How to remove - Two-piece bag ~ Use the tip of finger to pres	是	否	否
05701780179072	10458	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	是	否	否
05701780179096	10586	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	是	否	否
05701780179119	11433	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	是	否	否
05701780179133	11444	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	是	否	否
05701780179157	11453	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	是	否	否
05701780179171	11457	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	是	否	否
05701780179195	11492	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	是	否	否
05701780179218	11498	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	是	否	否
05701780179232	16406	Coloplas SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	是	否	否
05701780179256	16435	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	是	否	否
05701780179270	16810	Coloplas SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	是	否	否
05701780179294	16837	Coloplast SenSura Mio Ostomy Pouch and Accessories (Non-Sterile).	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。