CHANGZHOU BIOMET MEDICAL DEVICE
✅ Low Risk
FEI: 3012673613 • Changzhou, Jiangsu • CHINA
FEI Number
3012673613
Location
Changzhou, Jiangsu
Country
CHINAAddress
No 325 Chuang Xin Road, Wujin, Changzhou, Jiangsu, China
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 CHANGZHOU BIOMET MEDICAL DEVICE's FDA import refusal history?
CHANGZHOU BIOMET MEDICAL DEVICE (FEI: 3012673613) has 2 FDA import refusal record(s) in our database, spanning from 4/17/2020 to 4/17/2020.
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. CHANGZHOU BIOMET MEDICAL DEVICE's FEI number is 3012673613.
What types of violations has CHANGZHOU BIOMET MEDICAL DEVICE received?
CHANGZHOU BIOMET MEDICAL DEVICE 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 CHANGZHOU BIOMET MEDICAL DEVICE come from?
All FDA import refusal data for CHANGZHOU BIOMET MEDICAL DEVICE 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.