Taiwan FDA registration 25a4b5fcde7b103daa13b9e85bf7d0e3

"Shimai" Ovulation Test Card (Unsterilized)

TW: "時邁" 排卵測試卡 (未滅菌)

Taiwan·Risk Class 1·TONYAR BIOTECH. INC.·Registered Apr 28, 2016 – Apr 28, 2021Cancelled

Registration details

Analysis ID: 25a4b5fcde7b103daa13b9e85bf7d0e3

Company information

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

Product details

Intended Use: Limited to the first level recognition range of the "Luteinizing hormone test system (A.1485)" of the Measures for the Administration of Medical Devices.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1485 Progesterone testing system
Import Information: 國產;; 委託製造;; QMS/QSD

Dates and status

Registration Date: Apr 28, 2016
Expiry Date: Apr 28, 2021
Cancellation Date: Oct 12, 2023

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for "Shimai" Ovulation Test Card (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 25a4b5fcde7b103daa13b9e85bf7d0e3 and manufactured by TONYAR BIOTECH. INC.. The authorized representative in Taiwan is SMILER CO., LTD..

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