Taiwan FDA registration 5baf857a50a9bf310174824c4dfa4727

"Kunibi" Manual Osteologic Surgery Instrument (Sterile/Unsterilized)

TW: "邦美" 手動式骨科手術器械 (滅菌/未滅菌)
Taiwan flagTaiwan·Risk Class 1·BIOMET ORTHOPEDICS·Registered Jul 06, 2016 – Jul 06, 2026Expired
Registration details
Analysis ID
5baf857a50a9bf310174824c4dfa4727
Customs Code
DHA09401674902
Company information
Manufacturer
BIOMET ORTHOPEDICS
Manufacturer Country
United States
Authorized Representative
ZIMMER BIOMET TAIWAN CO., LTD.
Product details
Intended Use
Limited to the classification and grading management measures of medical equipment "Manual orthopedic surgical instruments (N.4540)" first grade identification range.
Product Type (Level 1)
N Orthopedics
Product Type (Level 2)
N.4540 手動式骨科手術器械
Import Information
Input;; QMS/QSD
Dates and status
Registration Date
Jul 06, 2016
Expiry Date
Jul 06, 2026
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About this record

Access comprehensive regulatory information for "Kunibi" Manual Osteologic Surgery Instrument (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 5baf857a50a9bf310174824c4dfa4727 and manufactured by BIOMET ORTHOPEDICS. 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 UK LIMITED, 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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