Taiwan FDA registration 5ee3b1e86ea8b3bcd30f87e7aa00e8f3

"Azuma" introduction/drainage catheter and its accessories (sterilization)

TW: “梓源”導入/引流導管及其附件 (滅菌)

Taiwan·Risk Class 1·TOP-BOUND ENTERPRISE CO., LTD.·Registered Jan 15, 2013 – Jan 15, 2018Cancelled

Registration details

Analysis ID: 5ee3b1e86ea8b3bcd30f87e7aa00e8f3

Company information

Manufacturer: TOP-BOUND ENTERPRISE CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Human Origin Biotechnology Co.,Ltd

Product details

Intended Use: Limited to the scope of Grade 1 identification of "Introduction/Drainage Catheters and Their Accessories (I.4200)" under the Measures for the Administration of Medical Devices.
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4200 Incoming/Drainage Tubes and Accessories
Import Information: QMS/QSD;; 國產;; 委託製造

Dates and status

Registration Date: Jan 15, 2013
Expiry Date: Jan 15, 2018
Cancellation Date: Nov 15, 2019

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Azuma" introduction/drainage catheter and its accessories (sterilization) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5ee3b1e86ea8b3bcd30f87e7aa00e8f3 and manufactured by TOP-BOUND ENTERPRISE CO., LTD.. The authorized representative in Taiwan is Human Origin Biotechnology Co.,Ltd.

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