Taiwan FDA registration 17952028a3b964bf348f5ca5a8eee6e0

"Boreco" isolation gown (unsterilized)

TW: "博來珂" 隔離衣 (未滅菌)

Taiwan·Risk Class 1·ZHANGJIAGANG BLACKBOX PLASTIC PRODUCTS CO LTD.·Registered Jun 04, 2020 – Jun 04, 2025Expired

Registration details

Analysis ID: 17952028a3b964bf348f5ca5a8eee6e0
Customs Code: DHA09600420705

Company information

Manufacturer: ZHANGJIAGANG BLACKBOX PLASTIC PRODUCTS CO LTD.
Manufacturer Country: China
Authorized Representative: ACARE TECHNOLOGY CO., LTD.

Product details

Intended Use: Limited to the first level identification range of medical equipment classification and grading management measures "Medical clothing (I.4040)".
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4040 Clothing for medical purposes
Import Information: Input;; Chinese goods

Dates and status

Registration Date: Jun 04, 2020
Expiry Date: Jun 04, 2025

About this record

Access comprehensive regulatory information for "Boreco" isolation gown (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 17952028a3b964bf348f5ca5a8eee6e0 and manufactured by ZHANGJIAGANG BLACKBOX PLASTIC PRODUCTS CO LTD.. The authorized representative in Taiwan is ACARE TECHNOLOGY CO., LTD..

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