Taiwan FDA registration 08ca6a59b6d8c1f6afdc58babae4efcc

"Edaifu" dressing change kit (sterilized)

TW: "億代富"換藥包(滅菌)

Taiwan·Risk Class 1·LIH YOW ENTERPRISE CO., LTD.·Registered Mar 18, 2011 – Mar 18, 2021Cancelled

Registration details

Analysis ID: 08ca6a59b6d8c1f6afdc58babae4efcc

Company information

Manufacturer: LIH YOW ENTERPRISE CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: MEDIFLY CO., LTD.

Product details

Intended Use: It is limited to the first level of identification scope of "external use of non-absorbent gauze or sponge ball (I.4014)", "manual instruments for general surgery (I.4800)" and "absorbent fiber for medical use (J.5300)" under the Measures for the Administration of Medical Devices.
Product Type (Level 1): J General hospital and personal use equipment;; I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4800 Manual instruments for general surgery; J.5300 Absorbent fibers for medical use;; I.4014 Non-absorbent gauze or sponge balls are used externally
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Mar 18, 2011
Expiry Date: Mar 18, 2021
Cancellation Date: Sep 08, 2023

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for "Edaifu" dressing change kit (sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 08ca6a59b6d8c1f6afdc58babae4efcc and manufactured by LIH YOW ENTERPRISE CO., LTD.. The authorized representative in Taiwan is MEDIFLY CO., LTD..

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