Taiwan FDA registration 0782a39998ea20ef295d16f8d5065c6c

"McVi" diaphragmatic potential catheter

TW: “邁柯唯”横膈膜電位導管

Taiwan·Risk Class 2·MAQUET CRITICAL CARE AB;; Maquet Cardiopulmonary Medikal Teknik San. Twitch. Ltd. Sti.·Registered Oct 09, 2019 – Oct 09, 2024Expired

Registration details

Analysis ID: 0782a39998ea20ef295d16f8d5065c6c
Customs Code: DHA05603297305

Company information

Manufacturer: MAQUET CRITICAL CARE AB;; Maquet Cardiopulmonary Medikal Teknik San. Twitch. Ltd. Sti.
Manufacturer Country: Türkiye;;Sweden
Authorized Representative: GETINGE GROUP TAIWAN CO., LTD.

Product details

Intended Use: The diaphragm potential catheter Edi Catheter is mainly used to detect the electrical activity (EDI signal) of the diaphragm point, control the two ventilation modes (NAVA and NIV NAVA), detect the electrical activity of the diaphragm point (EDI signal), monitor the respiratory drive of the brain (EDI signal), and administer nutraceuticals, fluids and therapeutic drugs through the nasogastrointestinal route. The diaphragmatic potential catheter Edi Catheter ENFit is mainly used for administering nutraceuticals, fluids and therapeutic drugs through the nasogastric tube route, aspiration through the nasogastric tube pathway, and transferring electrical activity (EDI signaling) to compatible SERVO ventilation devices suitable for NAVA and NIV NAVA.
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H.5980 Gastric insulal tube and its accessories
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Oct 09, 2019
Expiry Date: Oct 09, 2024

About this record

Access comprehensive regulatory information for "McVi" diaphragmatic potential catheter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0782a39998ea20ef295d16f8d5065c6c and manufactured by MAQUET CRITICAL CARE AB;; Maquet Cardiopulmonary Medikal Teknik San. Twitch. Ltd. Sti.. The authorized representative in Taiwan is GETINGE GROUP TAIWAN CO., LTD..

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