Taiwan FDA registration 858da17b09c2ecd4005169e2d48bfc3a

"Kunibi" Manual instrument for general surgery (sterile/unsterilized)

TW: "邦美" 一般手術用手動式器械 (滅菌/未滅菌)
Taiwan flagTaiwan·Risk Class 1·BIOMET SPORTS MEDICINE·Registered Dec 26, 2016 – Dec 26, 2026Active
Registration details
Analysis ID
858da17b09c2ecd4005169e2d48bfc3a
Customs Code
DHA09401733901
Company information
Manufacturer Country
United States
Authorized Representative
ZIMMER BIOMET TAIWAN CO., LTD.
Product details
Intended Use
Limited to the first level identification scope of the "Manual Instruments for General Surgery (I.4800)" of the Measures for the Classification and Grading Management of Medical Equipment.
Product Type (Level 1)
I General, Plastic Surgery and Dermatology
Product Type (Level 2)
I.4800 Hand Instruments for General Surgery
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Dec 26, 2016
Expiry Date
Dec 26, 2026
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About this record

Access comprehensive regulatory information for "Kunibi" Manual instrument for general surgery (sterile/unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 858da17b09c2ecd4005169e2d48bfc3a and manufactured by BIOMET SPORTS MEDICINE. The authorized representative in Taiwan is ZIMMER BIOMET TAIWAN CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including BIOMET ORTHOPEDICS, and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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