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CJ EZ Drop CEA Test - Taiwan Registration 3b3021a7a224f8dc994e6f84e9f590fd

Access comprehensive regulatory information for CJ EZ Drop CEA Test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3b3021a7a224f8dc994e6f84e9f590fd and manufactured by Qizhe Biotechnology Co., Ltd. The authorized representative in Taiwan is Qizhe Biotechnology Co., Ltd.

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3b3021a7a224f8dc994e6f84e9f590fd
Registration Details
Taiwan FDA Registration: 3b3021a7a224f8dc994e6f84e9f590fd
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Device Details

CJ EZ Drop CEA Test
TW: ๅ•Ÿๅ“ฒๆ˜“ๆปด็™Œ่ƒšๆŠ—ๅŽŸ้ซ”ๅค–่ฉฆๅŠ‘็ต„
Risk Class 2
MD

Registration Details

3b3021a7a224f8dc994e6f84e9f590fd

Ministry of Health Medical Device Manufacturing No. 005605

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 carcinoembryonic antigen (CEA) 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