Taiwan FDA registration 9e283d1f424232fed48529f35a42de59

"Epipar" Adhesive intraoral wound dressing (unsterilized)

TW: “貼必安” 可貼式口內傷口敷料(未滅菌)

Taiwan·Risk Class 1·BIOSTECH CO., LTD.;; TBM CORPORATION·Registered Apr 11, 2022 – Apr 11, 2027Active

Registration details

Analysis ID: 9e283d1f424232fed48529f35a42de59
Customs Code: DHA09402277900

Company information

Manufacturer: BIOSTECH CO., LTD.;; TBM CORPORATION
Manufacturer Country: Korea, Republic of
Authorized Representative: HONG YANG BIOTECHNOLOGY 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: 輸入;; QMS/QSD;; 委託製造

Dates and status

Registration Date: Apr 11, 2022
Expiry Date: Apr 11, 2027

About this record

Access comprehensive regulatory information for "Epipar" Adhesive intraoral wound dressing (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 9e283d1f424232fed48529f35a42de59 and manufactured by BIOSTECH CO., LTD.;; TBM CORPORATION. The authorized representative in Taiwan is HONG YANG BIOTECHNOLOGY CO., LTD..

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