Taiwan FDA registration 8a8d4c90d63cadc09af9ecfa92d7c78b

"Quick test" Clostridium difficile antigen rapid test reagent (unsterilized)

TW: “速測”困難梭狀桿菌抗原快速檢驗試劑(未滅菌)

Taiwan·Risk Class 1·CERTEST BIOTEC S.L.·Registered Jul 10, 2012 – Jul 10, 2017Cancelled

Registration details

Analysis ID: 8a8d4c90d63cadc09af9ecfa92d7c78b
Customs Code: DHA04401192708

Company information

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

Product details

Intended Use: Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Microbial Identification and Measurement Equipment (C.2660)".
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.2660 微生物鑑別及測定器材
Import Information: import

Dates and status

Registration Date: Jul 10, 2012
Expiry Date: Jul 10, 2017
Cancellation Date: Jan 18, 2019

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Quick test" Clostridium difficile antigen 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 8a8d4c90d63cadc09af9ecfa92d7c78b and manufactured by CERTEST BIOTEC S.L.. The authorized representative in Taiwan is JOLEX INTERNATIONAL CO., LTD..

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