Taiwan FDA registration 38d40d4dcd8f2e8d2a11b5a1f562bcef

"Opron" respiratory fusion cell virus-adenovirus assay (unsterilized)

TW: “歐普隆” 呼吸道融合細胞病毒-腺病毒檢驗試劑(未滅菌)

Taiwan·Risk Class 1·OPERON, S.A.·Registered Oct 13, 2021 – Oct 13, 2026Active

Registration details

Analysis ID: 38d40d4dcd8f2e8d2a11b5a1f562bcef
Customs Code: DHA09402267205

Company information

Manufacturer: OPERON, S.A.
Manufacturer Country: Spain
Authorized Representative: GREAT MEDICAL SCIENCE INC.

Product details

Intended Use: Limited to the classification and grading management of medical devices, the first level identification range of "adenovirus serum reagent (C.3020)" and "respiratory fusion cell virus serum reagent (C.3480)".
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3480 呼吸道融合細胞病毒血清試劑;; C.3020 腺病毒血清試劑
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Oct 13, 2021
Expiry Date: Oct 13, 2026

About this record

Access comprehensive regulatory information for "Opron" respiratory fusion cell virus-adenovirus assay (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 38d40d4dcd8f2e8d2a11b5a1f562bcef and manufactured by OPERON, S.A.. The authorized representative in Taiwan is GREAT MEDICAL SCIENCE INC..

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