Taiwan FDA registration 345418392d9d5008845992c34203ef3d

"Dongyao" three urine test cards (unsterilized)

TW: “東耀”三項驗尿卡 (未滅菌)

Taiwan·Risk Class 1·TONYAR BIOTECH. INC.·Registered Dec 17, 2014 – Dec 17, 2029Active

Registration details

Analysis ID: 345418392d9d5008845992c34203ef3d

Company information

Manufacturer: TONYAR BIOTECH. INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: TONYAR BIOTECH. INC.

Product details

Intended Use: It is limited to the first level of identification scope of the "Leukocyte Peroxidase Test (B.7675)", "Uric Base (Non-quantitative) Test System (A.1550)" and "Nitrite (Non-quantitative) Test System (A.1510)" of the Administrative Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1550 Uric pH (non-quantitative) testing system;; B.7675 Leukocyte peroxidase test;; A.1510 Nitrite (non-quantitative) test system
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Dec 17, 2014
Expiry Date: Dec 17, 2029

About this record

Access comprehensive regulatory information for "Dongyao" three urine test cards (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 345418392d9d5008845992c34203ef3d and manufactured by TONYAR BIOTECH. INC.. The authorized representative in Taiwan is TONYAR BIOTECH. INC..

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