Taiwan FDA registration 4e04f1ed43d687532266472ed1529a57

"Fente Hai" bone cement delivery system (sterilization)

TW: "汎特海" 骨水泥輸送系統(滅菌)

Taiwan·Risk Class 1·Kinrui Bio Limited;; Zhenpeng Biotech Co., Ltd·Registered Feb 20, 2023 – Feb 20, 2028Active

Registration details

Analysis ID: 4e04f1ed43d687532266472ed1529a57

Company information

Manufacturer: Kinrui Bio Limited;; Zhenpeng Biotech Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: XELITE BIOMED LTD.

Product details

Intended Use: It is limited to the first level identification range of "bone cement dispenser (N.4200)", "clinical bone cement agitator (N.4210)" and "manual orthopedic surgical instruments (N.4540)" of the classification and grading management measures for medical equipment.
Product Type (Level 1): N Orthopedics
Product Type (Level 2): N.4540 手動式骨科手術器械;; N.4210 臨床用骨水泥攪拌器;; N.4200 骨水泥分配器
Import Information: 國產;; QMS/QSD;; 委託製造

Dates and status

Registration Date: Feb 20, 2023
Expiry Date: Feb 20, 2028

About this record

Access comprehensive regulatory information for "Fente Hai" bone cement delivery system (sterilization) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 4e04f1ed43d687532266472ed1529a57 and manufactured by Kinrui Bio Limited;; Zhenpeng Biotech Co., Ltd. The authorized representative in Taiwan is XELITE BIOMED LTD..

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