Taiwan FDA registration f62120bcc4a13e27db464fc20df8cf1a

"Intec" Momoa cerebrovascular protection device

TW: “英泰克”莫瑪腦血管保護裝置

Taiwan·Risk Class 2·INVATEC S.P.A.·Registered Dec 29, 2010 – Dec 29, 2015Cancelled

Registration details

Analysis ID: f62120bcc4a13e27db464fc20df8cf1a
Customs Code: DHA00602179503

Company information

Manufacturer: INVATEC S.P.A.
Manufacturer Country: Italy
Authorized Representative: MEDTRONIC (TAIWAN) LTD.

Product details

Intended Use: The "Intec" Momoa cerebrovascular protection device is used for lesion angiography and stent implantation at ICA or carotid artery branches. [Note: Because the probability of intracranial vascular lesions in ischemic stroke patients in China is much higher than that of Westerners, it should be confirmed that the patient's intracranial blood vessels or circulation have no significant lesions or disorders before using this product, and the patient's neurological function should be closely monitored during the operation. The reference diameter for ECA (external carotid artery) is 3 to 6 mm, and the reference diameter for CCA (total carotid artery) is 5 to 13 mm.
Product Type (Level 1): E Cardiovascular Medicine Science
Import Information: import

Dates and status

Registration Date: Dec 29, 2010
Expiry Date: Dec 29, 2015
Cancellation Date: Aug 11, 2017

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Intec" Momoa cerebrovascular protection device in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f62120bcc4a13e27db464fc20df8cf1a and manufactured by INVATEC S.P.A.. The authorized representative in Taiwan is MEDTRONIC (TAIWAN) LTD..

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