Taiwan FDA registration 4a0b4b5f8e46e354ada1f1669cb82b2c

"Hongtai" bone cement kit (sterilized)

TW: “鴻泰” 骨水泥工具組(滅菌)

Taiwan·Risk Class 1·Shuoguo Biomedical Technology Co., Ltd.; Hongtai Biomedical Technology Co., Ltd·Registered Dec 22, 2021 – Dec 22, 2026Active

Registration details

Analysis ID: 4a0b4b5f8e46e354ada1f1669cb82b2c

Company information

Manufacturer: Shuoguo Biomedical Technology Co., Ltd.; Hongtai Biomedical Technology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: SUMMIT BIOMED. CO., LTD.

Product details

Intended Use: Limited to the classification and grading management of medical equipment, "Clinical bone cement mixer (N.4210)" and "bone cement dispenser (N.4200)" first level identification range.
Product Type (Level 1): N Orthopedics
Product Type (Level 2): N.4210 臨床用骨水泥攪拌器;; N.4200 骨水泥分配器
Import Information: 委託製造;; 國產;; QMS/QSD

Dates and status

Registration Date: Dec 22, 2021
Expiry Date: Dec 22, 2026

About this record

Access comprehensive regulatory information for "Hongtai" bone cement kit (sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 4a0b4b5f8e46e354ada1f1669cb82b2c and manufactured by Shuoguo Biomedical Technology Co., Ltd.; Hongtai Biomedical Technology Co., Ltd. The authorized representative in Taiwan is SUMMIT BIOMED. CO., LTD..

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