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CJ EZ Drop PSA Test - Taiwan Registration 31d42ae35468594c9b4dc85f64bed5ce

Access comprehensive regulatory information for CJ EZ Drop PSA Test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 31d42ae35468594c9b4dc85f64bed5ce and manufactured by Qizhe Biotechnology Co., Ltd. The authorized representative in Taiwan is Qizhe Biotechnology Co., Ltd.

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31d42ae35468594c9b4dc85f64bed5ce
Registration Details
Taiwan FDA Registration: 31d42ae35468594c9b4dc85f64bed5ce
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Device Details

CJ EZ Drop PSA Test
TW: ๅ•Ÿๅ“ฒๆ˜“ๆปดๅ‰ๅˆ—่…บ็‰น็•ฐๆ€งๆŠ—ๅŽŸ้ซ”ๅค–่ฉฆๅŠ‘็ต„
Risk Class 2
MD

Registration Details

31d42ae35468594c9b4dc85f64bed5ce

Ministry of Health Medical Device Manufacturing No. 005604

Company Information

Taiwan, Province of China

Product Details

Performance change: This product is used with Qizhe Color Analyzer (Weibu Medical Instrument No. 007660), which can quantitatively detect the concentration of prostate-specific antigen (PSA) in human serum.

C Immunology and microbiology devices

C6010 Tumor-associated antigen immunoassay system

Produced in Taiwan, China

Dates and Status

Apr 21, 2017

Apr 21, 2022