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KETOSURE POC Blood Ketone Test Strip (Non-Sterile) - Taiwan Registration b9115de46072cc477fcd42d9f3b3f71b

Access comprehensive regulatory information for KETOSURE POC Blood Ketone Test Strip (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b9115de46072cc477fcd42d9f3b3f71b and manufactured by APEX BIOTECHNOLOGY CORPORATION. The authorized representative in Taiwan is APEX BIOTECHNOLOGY CORPORATION.

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b9115de46072cc477fcd42d9f3b3f71b
Registration Details
Taiwan FDA Registration: b9115de46072cc477fcd42d9f3b3f71b
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Device Details

KETOSURE POC Blood Ketone Test Strip (Non-Sterile)
TW: ๆฌฃ่ˆ’ๆธฌๅฐˆๆฅญๅž‹่ก€้…ฎๆธฌ่ฉฆ็‰‡ (ๆœชๆป…่Œ)
Risk Class 1
MD

Registration Details

b9115de46072cc477fcd42d9f3b3f71b

Ministry of Health Medical Device Manufacturing No. 008468

Company Information

Taiwan, Province of China

Product Details

Limited to the first level identification range of the "Ketone (Non-quantitative) Test System (A.1435)" of the Measures for the Administration of Medical Devices.

A Clinical chemistry and clinical toxicology

A1435 Ketone (non-quantitative) test system

Produced in Taiwan, China

Dates and Status

Jul 27, 2020

Jul 27, 2025