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"Broadcom" blood ketone test system (unsterilized) - Taiwan Registration b6cc9df49f3b0f1ed023c46a11f1130c

Access comprehensive regulatory information for "Broadcom" blood ketone test system (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b6cc9df49f3b0f1ed023c46a11f1130c and manufactured by BROADMASTER BIOTECH. CORP.. The authorized representative in Taiwan is BROADMASTER BIOTECH. CORP..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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b6cc9df49f3b0f1ed023c46a11f1130c
Registration Details
Taiwan FDA Registration: b6cc9df49f3b0f1ed023c46a11f1130c
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Device Details

"Broadcom" blood ketone test system (unsterilized)
TW: โ€œๅš้€šโ€่ก€้…ฎๆธฌ่ฉฆ็ณป็ตฑ(ๆœชๆป…่Œ)
Risk Class 1

Registration Details

b6cc9df49f3b0f1ed023c46a11f1130c

Company Information

Taiwan, Province of China

Product Details

The classification and grading management measures for medical equipment are limited to the first level identification range of "ketone (non-quantitative) test system (A.1435)" and "manual instruments for general surgery (I.4800)".

A Clinical Chemistry and Clinical Toxicology;; I General, Plastic Surgery and Dermatology

A.1435 Ketone (non-quantitative) testing system;; I.4800 Manual instruments for general surgery

ๅœ‹็”ข;; QMS/QSD

Dates and Status

Sep 30, 2021

Sep 30, 2026