Taiwan FDA registration 5452937b2a55a41708a26e5cc15fd4cc

"Didan" Cardiovascular Surgical Instrument (Incisive)

TW: "帝丹" 心臟血管外科器械 (未滅菌)

Taiwan·Risk Class 1·TEDAN SURGICAL INNOVATIONS, INC.·Registered Oct 07, 2024 – Oct 07, 2029Active

Registration details

Analysis ID: 5452937b2a55a41708a26e5cc15fd4cc
Customs Code: DHA09402362208

Company information

Manufacturer: TEDAN SURGICAL INNOVATIONS, INC.
Manufacturer Country: United States
Authorized Representative: ASIA HEALTH CARE CO., LTD.

Product details

Intended Use: It is limited to the scope of first-class identification of cardiovascular surgical devices (E.4500) in the classification and grading management measures for medical devices.
Product Type (Level 1): E Cardiovascular Medicine Science
Product Type (Level 2): E.4500 心臟血管外科器械
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Oct 07, 2024
Expiry Date: Oct 07, 2029

About this record

Access comprehensive regulatory information for "Didan" Cardiovascular Surgical Instrument (Incisive) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5452937b2a55a41708a26e5cc15fd4cc and manufactured by TEDAN SURGICAL INNOVATIONS, INC.. The authorized representative in Taiwan is ASIA HEALTH CARE CO., LTD..

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