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KETOSURE POC Blood Ketone Monitoring System (Non-Sterile) - Taiwan Registration 3c86eb2c1d648f6685003091be7cdf02

Access comprehensive regulatory information for KETOSURE POC Blood Ketone Monitoring System (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 3c86eb2c1d648f6685003091be7cdf02 and manufactured by APEX BIOTECHNOLOGY CORPORATION. The authorized representative in Taiwan is APEX BIOTECHNOLOGY CORPORATION.

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3c86eb2c1d648f6685003091be7cdf02
Registration Details
Taiwan FDA Registration: 3c86eb2c1d648f6685003091be7cdf02
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Device Details

KETOSURE POC Blood Ketone Monitoring System (Non-Sterile)
TW: ๆฌฃ่ˆ’ๆธฌๅฐˆๆฅญๅž‹่ก€้…ฎๆธฌ่ฉฆ็ณป็ตฑ(ๆœชๆป…่Œ)
Risk Class 1
MD

Registration Details

3c86eb2c1d648f6685003091be7cdf02

Ministry of Health Medical Device Manufacturing No. 008520

DHY09300852009

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

Aug 14, 2020

Aug 14, 2025