Taiwan FDA registration ed72f5b931897a8da394a1a17234a75b

"Badielk" Rotavirus/Adenovirus Test Reagent (Unsterilized)

TW: “巴迪鐵克” 輪狀病毒/腺病毒檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·Boditech Med Inc.·Registered Aug 10, 2021 – Aug 10, 2026Active

Registration details

Analysis ID: ed72f5b931897a8da394a1a17234a75b
Customs Code: DHA09402260605

Company information

Manufacturer: Boditech Med Inc.
Manufacturer Country: Korea, Republic of
Authorized Representative: MEDRICH INSTRUMENT CO., LTD.

Product details

Intended Use: Limited to the classification and grading management of medical devices, the first level of "polio virus serum reagent (C.3405)" and "adenovirus serum reagent (C.3020)" identification range.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3020 腺病毒血清試劑;; C.3405 小兒麻痺病毒血清試劑
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Aug 10, 2021
Expiry Date: Aug 10, 2026

About this record

Access comprehensive regulatory information for "Badielk" Rotavirus/Adenovirus Test Reagent (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number ed72f5b931897a8da394a1a17234a75b and manufactured by Boditech Med Inc.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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