台灣醫療器材
許可證資料查詢
MEDCHECK許可證索引
衛部醫器輸字
許可證編號
032603
輸入器材
醫療器材許可證 / 輸入器材

“可立”超音波系統及其附件

“Koelis” TRINITY

衛部醫器輸字第032603號
本站收錄狀態核准有效
有效日期2029 / 05 / 08
醫療器材級數第二等級

申請商為 台美醫療器材股份有限公司,收錄 33 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032603號
申請商
台美醫療器材股份有限公司 (查看此申請商全部許可證)
統一編號
54675683
申請商地址
臺北市大安區敦化南路2段168號5樓
發證日期
2019 / 05 / 08
有效日期
2029 / 05 / 08
限制項目
輸 入
資料異動日期
2024 / 02 / 17

這類器材是什麼 超音波回音影像系統,AI 輔助整理

超音波回音影像系統就是用高頻音波照出體內影像的機器,也就是俗稱的超音波。它不開刀、不照輻射,常用來看腹部、心臟、血管、眼睛、膀胱等軟組織。

它跟 X 光、電腦斷層差在哪

超音波用音波反射成像,沒有游離輻射,孕婦產檢、小兒檢查常用它。X 光和電腦斷層用輻射穿透身體,看骨骼和肺部比較清楚。核磁共振用磁場,沒有輻射但機器大、檢查時間長。這幾種各有擅長看的部位,醫師會依需要安排。

誰會用到它

超音波幾乎是醫院最常見的影像工具之一,不同科別會搭配不同型式的機器。

  • 腹部、婦產科:看肝膽、腎臟、子宮、胎兒。
  • 心臟血管:看心臟結構、血流,也有伸進血管內的血管內超音波。
  • 眼科:看眼球結構,品名裡就有眼科用超音波。
  • 泌尿科:膀胱掃描儀、膀胱容積測量儀用來量膀胱裡有多少尿。
  • 肝臟檢查:剪切波超音波用來定量肝纖維化程度。
  • 穿刺、切片:搭配穿刺導引器或針具追蹤系統,協助定位。

檢查時會遇到什麼

多數檢查是體表掃描,在皮膚塗一層凝膠,用探頭滑過去,不會痛。少數檢查要把探頭伸進體內,例如經陰道、經直腸或血管內,這類探頭會清潔消毒或使用無菌套。本站收錄的型號裡,標示單次使用的比例很低,多數探頭是重複使用、每次檢查後清潔消毒。檢查前要不要禁食、憋尿,依檢查部位而定,預約時會告知。

怎麼知道買到或用到的是合法機器

超音波影像系統在台灣是第 2 等級醫療器材,要有醫療器材許可證才能製造、輸入、販售。目前有效的許可證有 73 張,其中只有 1 張是國內製造,其餘都是進口,來源以美國最多,其次中國、南韓、法國。

  • 看機身或標籤上的許可證字號:「衛部醫器輸字第○○○○○○號」是進口,「製」字是國內製造。
  • 字號可以查是否還有效,也可以核對品名和型號跟機器是否一致。
  • 這類機器由醫療院所採購、由原廠或代理商安裝與維護,一般民眾不會自己買。
  • 如果看到來路不明、沒有字號的機器在非醫療場所收費做檢查,要留意。

常見問題

超音波檢查有輻射嗎?

沒有。超音波用的是高頻音波,不是游離輻射,所以孕婦產檢、小朋友檢查都常使用。它和 X 光、電腦斷層的成像原理完全不同,不會有輻射暴露的問題。

超音波可以檢查所有器官嗎?

不行。音波遇到空氣和骨骼會被擋住,所以肺部和腸胃道裡的氣體會干擾影像,骨頭後面的構造也看不清楚。這些部位通常要靠 X 光、電腦斷層或核磁共振。超音波強在看軟組織和液體。

照超音波前要禁食或憋尿嗎?

不一定,看檢查部位。照上腹部(肝膽胰)通常要禁食幾小時,讓膽囊脹大、減少腸氣;照骨盆腔、膀胱則常需要憋尿,讓膀胱脹起來當音窗。預約時醫護人員會告訴你怎麼準備。

超音波機器需要定期保養嗎?

需要。探頭是精密又怕摔的零件,表面有裂痕會影響影像,也可能藏汙納垢。醫療院所會依原廠建議做清潔消毒和定期維護,探頭故障或影像異常時要停用送修。

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
詳如中文仿單核定本
規格
TRINITY,以下空白。
新增規格:詳如中文仿單核定本(原108年5月27日仿單標籤核定本收回作廢)。
規格變更:詳如中文仿單核定本(原108年8月21日核定之仿單標籤核定本收回作廢)。
增加規格:詳如核定之中文說明書(原109年2月11日核定之標籤、說明書或包裝予以收回作廢)。
註銷規格:KRNG.EL2、KRNG.LN、KRNG.AB。

製造廠

製造商
KOELIS
國別
法國
廠址
22, Chemin du Vieux Chêne, 38240 Meylan, France
製造許可登錄編號
QSD14362

UDI 型號 共 33 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
03665134000011KDNG00The product concerned is a plastic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access. The guide is composed of 2 parts welded together to have: • a channel to receive and guide the linear instrument • a clip to allow the guide stability on the transducer • 2 pins for attachment in the notches of the probe • a guide cone to introduce easily the needle into the tube 是 否 否
03665134000035KURO-3000-2A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart, Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse. 否 否 否
03665134000059GPK490The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access. Sold *5 否 否 否
03665134000219KRNG.EL1.14PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane. The guides are reusable medical devices. 否 否 否
03665134000226KRNG.EL1.18PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane. The guides are reusable medical devices. 否 否 否
03665134000233KRNG.EL2.18PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane. The guides are reusable medical devices. 否 否 否
03665134000240KRNG.EL2.14PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane. The guides are reusable medical devices. 否 否 否
03665134000257KRNG.EL4.18The guides from PERINE range are intended to guide a needle during ultrasound-guided intervention. PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane. The guides are reusable medical devices. 否 否 否
03665134000264KRNG.EL4.14The guides from PERINE range are intended to guide a needle during ultrasound-guided intervention. PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane. The guides are reusable medical devices. 否 否 否
03665134000271KRGA.EL5PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane. The guides are reusable medical devices. 否 否 否
03665134000288KRNG.AB.18Needle guide compatible with the abdominal 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound probe. The other removable part is perforated and inserted in the first part to guide the needle. The device is designed to guide needles with a diameter from 17G to 20G. The guides are reusable after appropriate procedure. They are not delivered in sterile condition 否 否 否
03665134000295KRNG.AB.14Needle guide compatible with the abdominal 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound probe. The other removable part is perforated and inserted in the first part to guide the needle. The device is designed to guide needles with a diameter from 14G to 16G. The guides are reusable after appropriate procedure. They are not delivered in sterile condition 否 否 否
03665134000301KRNG.LN.18Needle guide compatible with the linear 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound probe. The other removable part is perforated and inserted in the first part to guide the needle. The device is designed to guide needles with a diameter from 17G to 20G. The guides are reusable after appropriate procedure. They are not delivered in sterile condition 否 否 否
03665134000318KRNG.LN.14Needle guide compatible with the linear 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound probe. The other removable part is perforated and inserted in the first part to guide the needle. The device is designed to guide needles with a diameter from 14G to 16G. The guides are reusable after appropriate procedure. They are not delivered in sterile condition 否 否 否
03665134000325NAIL.14the device Nail.14 is used to guide linear instruments such as needle during, for example, ultrasound guided biopsy procedure. The nail.14 is compatible with needles from 14 to 16 gauge. The device is reusable but must be sterilized before use. The device is not provided in sterile condition. 否 否 否
03665134000332NAIL.18Nails are used to guide linear instruments such as needles for application such as ultrasound biopsy guided procedure. The NAIL.18 can be used with needles from 17 to 20 Gauge. 否 否 否
03665134000417KPHA.01.ECSteady Pro support for Full-3D endocavity end-fire probe 否 否 否
03665134000424KPHA.EC.2Steady Pro support for Full-3D endocavity end-fire probe 否 否 否
03665134000448KPHA.01.ELSteady Pro support for Full-3D endocavity side-fire probe 否 否 否
03665134000493KPHA.EL.2Steady Pro support for Full-3D endocavity side-fire probe 否 否 否
03665134000523K2DAB00Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, soft tissues, Urology and Vascular applications Frequencies: 2-5MHz Field of view 460° Radius 60 mm 否 否 否
03665134000561KPHA.00Steady Pro (Mechanical probe holder and supports) The steady pro range is intended to reliably maintain the position of a transrectal ultrasoung probe during untra-sound-guided intervention. 否 否 否
03665134000578KURO-4000A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy. 否 否 否
03665134000738KSP.ARMSteady Pro Probe Holding Arm with I and U extension and rail clamping base The Steady Pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention. 否 否 否
03665134000752KSP.SUPP.TPProbe holder for transperineal approach. The steady pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention. 否 否 否
03665134000783KSP.SUPP.TRProbe holder for transrectal approach 否 否 否
03665134000806KSP.UnivClampUniversal clamping base The steady pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention. 否 否 否
03665134000820GPK490The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access. Sold *5 否 否 否
03665134000929KURO-4000A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy. 否 否 否
03665134000509K3DEC00-2Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology and gynecology applications. Frequencies: 4-9 MHz Field of view 146° Scanning angle 90° Radius 10 mm 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。