Taiwan FDA registration d0da1b48f7bb29f360fc2a1a724f77fb

Oplong Rotavirus/Adenovirus Rapid Test (Unsterilized)

TW: “歐普隆”輪狀病毒/腺病毒快速檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·OPERON, S.A.·Registered Apr 09, 2021 – Apr 09, 2026Expired

Registration details

Analysis ID: d0da1b48f7bb29f360fc2a1a724f77fb
Customs Code: DHA09402246003

Company information

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

Product details

Intended Use: It is limited to the first-level identification scope of the "Adenovirus Serum Reagent (C.3020)" and "Poliovirus Serum Reagent (C.3405)" of the Classification and Grading Management Measures for Medical Devices.
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: import

Dates and status

Registration Date: Apr 09, 2021
Expiry Date: Apr 09, 2026

About this record

Access comprehensive regulatory information for Oplong Rotavirus/Adenovirus Rapid Test (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number d0da1b48f7bb29f360fc2a1a724f77fb and manufactured by OPERON, S.A.. The authorized representative in Taiwan is GREAT MEDICAL SCIENCE INC..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.