Chang Gung Medical Technology Co. Ltd.
✅ Low Risk
FEI: 3010199906 • Taipei • TAIWAN
FEI Number
3010199906
Location
Taipei
Country
TAIWANAddress
11f, No. 201-4, Tung Hwa North Road, , Taipei, , Taiwan
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Chang Gung Medical Technology Co. Ltd.'s FDA import refusal history?
Chang Gung Medical Technology Co. Ltd. (FEI: 3010199906) has 2 FDA import refusal record(s) in our database, spanning from 7/17/2013 to 7/17/2013.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Chang Gung Medical Technology Co. Ltd.'s FEI number is 3010199906.
What types of violations has Chang Gung Medical Technology Co. Ltd. received?
Chang Gung Medical Technology Co. Ltd. has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Chang Gung Medical Technology Co. Ltd. come from?
All FDA import refusal data for Chang Gung Medical Technology Co. Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.