Taiwan FDA registration ce3a0eb5a9d0c27ae0eb8e38d09952df

"Quick Test" Enterovirus Rapid Test Reagent (Unsterilized)

TW: "速測" 腸病毒快速檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·CERTEST BIOTEC, S.L.·Registered Apr 10, 2017 – Apr 10, 2022Cancelled

Registration details

Analysis ID: ce3a0eb5a9d0c27ae0eb8e38d09952df
Customs Code: DHA09401769102

Company information

Manufacturer: CERTEST BIOTEC, S.L.
Manufacturer Country: Spain
Authorized Representative: JOLEX INTERNATIONAL CO., LTD.

Product details

Intended Use: It is limited to the first level identification range of "Kosachi virus serum reagent (C.3145)", "Iko virus serum reagent (C.3205)" and "polio virus serum reagent (C.3405)" under the management measures for medical devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3205 伊科病毒血清試劑;; C.3145 柯沙奇病毒血清試劑;; C.3405 小兒麻痺病毒血清試劑
Import Information: import

Dates and status

Registration Date: Apr 10, 2017
Expiry Date: Apr 10, 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 "Quick Test" Enterovirus 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 ce3a0eb5a9d0c27ae0eb8e38d09952df and manufactured by CERTEST BIOTEC, S.L.. The authorized representative in Taiwan is JOLEX INTERNATIONAL CO., LTD..

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