Taiwan FDA registration 037f773466684c42d3776f55bef1fab9

Edai Dialysis Care Kit (Sterilized)

TW: “億代富”洗腎護理包 (滅菌)

Taiwan·Risk Class 1·LIH YOW ENTERPRISE CO., LTD.·Registered Nov 05, 2010 – Nov 05, 2025Expired

Registration details

Analysis ID: 037f773466684c42d3776f55bef1fab9

Company information

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

Product details

Intended Use: It is limited to the first level of identification scope of the Administrative Measures for the Classification and Grading of Medical Devices, "External Use of Non-absorbent Gauze or Sponge Balls (I.4014)", "Medical Absorbent Fibers (J.5300)", and "Absorbent Tip Applicator (J.6025)".
Product Type (Level 1): J General hospital and personal use equipment;; I General, Plastic Surgery and Dermatology
Product Type (Level 2): J.6025 Absorbent tip applicator;; J.5300 Absorbent fibers for medical use;; I.4014 Non-absorbent gauze or sponge balls are used externally
Import Information: QMS/QSD;; 國產;; 委託製造

Dates and status

Registration Date: Nov 05, 2010
Expiry Date: Nov 05, 2025
Cancellation Date: Feb 23, 2024

About this record

Access comprehensive regulatory information for Edai Dialysis Care 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 037f773466684c42d3776f55bef1fab9 and manufactured by LIH YOW ENTERPRISE CO., LTD.. The authorized representative in Taiwan is Egeneration International Limited.

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