Taiwan FDA registration 05a6751b88d191493c97e8cc61957fcd

「西海」可貼式口内傷口dressing (未滅bacteria)

TW: "西海"可貼式口內傷口敷料 (未滅菌)

Taiwan·Risk Class 1·BIOSTECH CO., LTD.;; TBM CORPORATION·Registered Nov 21, 2023 – Nov 21, 2028Active

Registration details

Analysis ID: 05a6751b88d191493c97e8cc61957fcd
Customs Code: DHA09402331502

Company information

Manufacturer: BIOSTECH CO., LTD.;; TBM CORPORATION
Manufacturer Country: Korea, Republic of
Authorized Representative: SEEHIGH BIOTECH 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: Nov 21, 2023
Expiry Date: Nov 21, 2028

About this record

Access comprehensive regulatory information for 「西海」可貼式口内傷口dressing (未滅bacteria) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 05a6751b88d191493c97e8cc61957fcd and manufactured by BIOSTECH CO., LTD.;; TBM CORPORATION. The authorized representative in Taiwan is SEEHIGH BIOTECH CO., LTD..

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