Taiwan FDA registration b6cc9df49f3b0f1ed023c46a11f1130c

"Broadcom" blood ketone test system (unsterilized)

TW: “博通”血酮測試系統(未滅菌)

Taiwan·Risk Class 1·BROADMASTER BIOTECH. CORP.·Registered Sep 30, 2021 – Sep 30, 2026Active

Registration details

Analysis ID: b6cc9df49f3b0f1ed023c46a11f1130c

Company information

Manufacturer: BROADMASTER BIOTECH. CORP.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: BROADMASTER BIOTECH. CORP.

Product details

Intended Use: 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)".
Product Type (Level 1): A Clinical Chemistry and Clinical Toxicology;; I General, Plastic Surgery and Dermatology
Product Type (Level 2): A.1435 Ketone (non-quantitative) testing system;; I.4800 Manual instruments for general surgery
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Sep 30, 2021
Expiry Date: Sep 30, 2026

About this record

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..

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