Taiwan FDA registration 6259ef037c6a5d9bd57ddacc16b1e923

"Bonthe" urine collection bag (unsterilized)

TW: "邦特" 尿液收集袋 (未滅菌)

Taiwan·Risk Class 1·Bonte Biotechnology Co., Ltd. Yilan Plant 2·Registered Feb 26, 2019 – Feb 26, 2029Active

Registration details

Analysis ID: 6259ef037c6a5d9bd57ddacc16b1e923

Company information

Manufacturer: Bonte Biotechnology Co., Ltd. Yilan Plant 2
Manufacturer Country: Taiwan, Province of China
Authorized Representative: BIOTEQUE CORPORATION

Product details

Intended Use: Limited to the first level identification range of the "urine collector and its accessories (H.5250)" of the Measures for the Classification and Grading Management of Medical Devices.
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H.5250 Urine Collector and Accessories Thereof
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Feb 26, 2019
Expiry Date: Feb 26, 2029

About this record

Access comprehensive regulatory information for "Bonthe" urine collection bag (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 6259ef037c6a5d9bd57ddacc16b1e923 and manufactured by Bonte Biotechnology Co., Ltd. Yilan Plant 2. The authorized representative in Taiwan is BIOTEQUE CORPORATION.

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