Taiwan FDA registration 3f2a91b211799851e0766f040740cbae

“Microdacyn Hydrogel” Super-Oxidised Solution

TW: “邁克欣”傷口清潔抗菌水凝膠

Taiwan·Risk Class 2·MD·Oculus Technologies of Mexico, S.A. de C.V.·Registered Sep 08, 2022 – Sep 08, 2027Active

Registration details

Analysis ID: 3f2a91b211799851e0766f040740cbae
License Form: Ministry of Health Medical Device Import No. 035804
Customs Code: DHA05603580400

Company information

Manufacturer: Oculus Technologies of Mexico, S.A. de C.V.
Manufacturer Country: Mexico
Authorized Representative: CHIAEN PHARMACEUTICAL CO., LTD.

Product details

Intended Use: This product is an electrolyzed hydrogel that can be used to debride and wet acute and chronic wounds, ulcers and scalds. This product keeps wounds moist and creates an optimal microenvironment to aid wound healing. This product contains sodium chloride, sodium hypochlorite and hypochlorous acid, not through pharmacology, immunology or metabolic pathways, but purely through physical processes to achieve bacteriostatic effect.
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I4022 Waterborne wound and burn coverings
Import Information: Imported from abroad

Dates and status

Registration Date: Sep 08, 2022
Expiry Date: Sep 08, 2027

About this record

Access comprehensive regulatory information for “Microdacyn Hydrogel” Super-Oxidised Solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3f2a91b211799851e0766f040740cbae and manufactured by Oculus Technologies of Mexico, S.A. de C.V.. The authorized representative in Taiwan is CHIAEN PHARMACEUTICAL CO., LTD..

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