Taiwan FDA registration 80c9dac1c6d2a7fc4cc99aca8127e023

EASEmed Prostate Special Antigen (PSA) Rapid Test Kit

TW: 醫試美攝護腺特異性抗原快速檢驗試劑

Taiwan·Risk Class 2·MD·Kaiwu Technology Co., Ltd. Nanke Factory·Registered Jan 13, 2014 – Jan 13, 2029Active

Registration details

Analysis ID: 80c9dac1c6d2a7fc4cc99aca8127e023
License Form: Ministry of Health Medical Device Manufacturing No. 004436

Company information

Manufacturer: Kaiwu Technology Co., Ltd. Nanke Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Kaiwu Technology Co., Ltd. Nanke Factory

Product details

Intended Use: This product is a qualitative detection of prostate-specific antigen in human serum.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C6010 Tumor-associated antigen immunoassay system
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Jan 13, 2014
Expiry Date: Jan 13, 2029

About this record

Access comprehensive regulatory information for EASEmed Prostate Special Antigen (PSA) Rapid Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 80c9dac1c6d2a7fc4cc99aca8127e023 and manufactured by Kaiwu Technology Co., Ltd. Nanke Factory. The authorized representative in Taiwan is Kaiwu Technology Co., Ltd. Nanke Factory.

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