Taiwan FDA registration 75611d0bed45fcbf6b9860c248d915e3

"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 03, 2012 – Apr 03, 2017Cancelled

Registration details

Analysis ID: 75611d0bed45fcbf6b9860c248d915e3
Customs Code: DHA04401155905

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 scope of "Cosackievirus Serum Reagent (C.3145)", "Echo Virus Serum Reagent (C.3205)" and "Poliomyelitis Virus Serum Reagent (C.3405)" under the Medical Device Management Measures.
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 03, 2012
Expiry Date: Apr 03, 2017
Cancellation Date: Jan 17, 2019

Cancellation information

Status: Logged out
Reason: 自行鍵入

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 75611d0bed45fcbf6b9860c248d915e3 and manufactured by CERTEST BIOTEC S.L.. The authorized representative in Taiwan is JOLEX INTERNATIONAL CO., LTD..

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.