Taiwan FDA registration 599cd4f3219dbf51da171744ab95987a

Dirk pylori antigen enzyme immunoassay (unsterilized)

TW: "德克"幽門桿菌抗原酵素免疫試劑(未滅菌)

Taiwan·Risk Class 1·Lingyue Biomedical Co., Ltd. Taipei Factory·Registered May 06, 2013 – May 06, 2018Cancelled

Registration details

Analysis ID: 599cd4f3219dbf51da171744ab95987a

Company information

Manufacturer: Lingyue Biomedical Co., Ltd. Taipei Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Dirk International Limited

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C0003)".
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.0003 螺旋桿菌屬血清試劑
Import Information: Contract manufacturing;; Domestic

Dates and status

Registration Date: May 06, 2013
Expiry Date: May 06, 2018
Cancellation Date: Feb 21, 2018

Cancellation information

Status: Logged out
Reason: 公司歇業

About this record

Access comprehensive regulatory information for Dirk pylori antigen enzyme immunoassay (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 599cd4f3219dbf51da171744ab95987a and manufactured by Lingyue Biomedical Co., Ltd. Taipei Factory. The authorized representative in Taiwan is Dirk International Limited.

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