Taiwan FDA registration 3249b0206ecf227b191ccbcc05d6a068
"Ruijun" respiratory fusion cell virus and adenovirus rapid test reagent (unsterilized)
TW: "睿軍" 呼吸道融合細胞病毒及腺病毒快速檢驗試劑 (未滅菌)
Registration details
- Analysis ID
- 3249b0206ecf227b191ccbcc05d6a068
- Customs Code
- DHA09401860909
Company information
- Manufacturer
- RAPIGEN INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Medley Limited
Product details
- Intended Use
- Limited to the first level of identification range of "respiratory fusion cell virus serum reagent (C.3480)" and "adenovirus serum reagent (C.3020)" under the 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.3480 呼吸道融合細胞病毒血清試劑
- Import Information
- import
Dates and status
- Registration Date
- Dec 14, 2017
- Expiry Date
- Dec 14, 2022
- Cancellation Date
- Apr 12, 2024
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Ruijun" respiratory fusion cell virus and adenovirus 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 3249b0206ecf227b191ccbcc05d6a068 and manufactured by RAPIGEN INC.. The authorized representative in Taiwan is Medley Limited.
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