Taiwan FDA registration 56b78d174426c058cc9631813509ab21

"Mouth closure" Intraoral wound dressings (unsterilized)

TW: "口合貼" 口內傷口敷料(未滅菌)

Taiwan·Risk Class 1·Aggregator Co., Ltd.;; Asahi Biotechnology Co., Ltd·Registered Feb 20, 2023 – Feb 20, 2028Active

Registration details

Analysis ID: 56b78d174426c058cc9631813509ab21

Company information

Manufacturer: Aggregator Co., Ltd.;; Asahi Biotechnology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: MoleculeX Co., Ltd.

Product details

Intended Use: Limited to the first level recognition range of the classification and grading management measures for medical equipment "hydrophilic trauma covering materials (I.4018)".
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4018 親水性創傷覆蓋材
Import Information: 國產;; QMS/QSD;; 委託製造

Dates and status

Registration Date: Feb 20, 2023
Expiry Date: Feb 20, 2028

About this record

Access comprehensive regulatory information for "Mouth closure" Intraoral wound dressings (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 56b78d174426c058cc9631813509ab21 and manufactured by Aggregator Co., Ltd.;; Asahi Biotechnology Co., Ltd. The authorized representative in Taiwan is MoleculeX Co., Ltd..

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