Taiwan FDA registration 4b7d707da5911c56db79dd9c5caeaa7b

"Oplon" Respiratory Fusion Cell Virus Rapid Test Reagent (Unsterilized)

TW: “歐普隆” 呼吸道融合細胞病毒快速檢驗試劑(未滅菌)

Taiwan·Risk Class 1·OPERON, S.A.·Registered Sep 22, 2021 – Sep 22, 2026Active

Registration details

Analysis ID: 4b7d707da5911c56db79dd9c5caeaa7b
Customs Code: DHA09402266001

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 "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
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Sep 22, 2021
Expiry Date: Sep 22, 2026

About this record

Access comprehensive regulatory information for "Oplon" Respiratory Fusion Cell Virus Rapid 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 4b7d707da5911c56db79dd9c5caeaa7b and manufactured by OPERON, S.A.. The authorized representative in Taiwan is GREAT MEDICAL SCIENCE INC..

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