Taiwan FDA registration f32fb2ffeb0ec383244a973cbc64ca70

"Intuition" endoscopic surgical instrument control system

TW: “直覺”內視鏡手術器械控制系統
Taiwan flagTaiwan·Risk Class 2·INTUITIVE SURGICAL, INC.·Registered Jun 01, 2022 – Jun 01, 2027Active
Registration details
Analysis ID
f32fb2ffeb0ec383244a973cbc64ca70
Customs Code
DHA05603549306
Company information
Manufacturer Country
United States
Product details
Intended Use
This system is intended to assist in accurate control of Intuitive Surgical endoscopic instruments in base resection of the tongue in patients with obstructive sleep apnea, in urological surgery, general laparoscopic surgery, in general thoracoscopic surgery, nipple-sparing mastectomy reconstruction, cardiac surgery, transoral otolaryngology surgery (benign tumors and T1 and T2 malignancies only), and in tongue base resection in patients with obstructive sleep apnea. This system is suitable for use by both adults and children (except for oral ENT surgery). This product must be used by a trained physician in an operating room setting.
Product Type (Level 1)
H Gastroenterology and urology
Product Type (Level 2)
H.1500 Internal Scope and its accessories
Import Information
import
Dates and status
Registration Date
Jun 01, 2022
Expiry Date
Jun 01, 2027
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About this record

Access comprehensive regulatory information for "Intuition" endoscopic surgical instrument control system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f32fb2ffeb0ec383244a973cbc64ca70 and manufactured by INTUITIVE SURGICAL, INC.. The authorized representative in Taiwan is INTUITIVE SURGICAL SARL TAIWAN BRANCH (SWITZERLAND).

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Intuitive Surgical, Inc., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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