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"Fente Hai" bone cement delivery system (sterilization) - Taiwan Registration 4e04f1ed43d687532266472ed1529a57

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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4e04f1ed43d687532266472ed1529a57
Registration Details
Taiwan FDA Registration: 4e04f1ed43d687532266472ed1529a57
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Device Details

"Fente Hai" bone cement delivery system (sterilization)
TW: "ๆฑŽ็‰นๆตท" ้ชจๆฐดๆณฅ่ผธ้€็ณป็ตฑ(ๆป…่Œ)
Risk Class 1

Registration Details

4e04f1ed43d687532266472ed1529a57

Company Information

Taiwan, Province of China

Product Details

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.

N Orthopedics

N.4540 ๆ‰‹ๅ‹•ๅผ้ชจ็ง‘ๆ‰‹่ก“ๅ™จๆขฐ;; N.4210 ่‡จๅบŠ็”จ้ชจๆฐดๆณฅๆ”ชๆ‹Œๅ™จ;; N.4200 ้ชจๆฐดๆณฅๅˆ†้…ๅ™จ

ๅœ‹็”ข;; QMS/QSD;; ๅง”่จ—่ฃฝ้€ 

Dates and Status

Feb 20, 2023

Feb 20, 2028