Mech Tronic Precision Manufacturing Ltd
✅ Low Risk
FEI: 3007250267 • Huizhou • CHINA
FEI Number
3007250267
Location
Huizhou
Country
CHINAAddress
Jimadi Industrial Estate, , Huizhou, , 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 Mech Tronic Precision Manufacturing Ltd's FDA import refusal history?
Mech Tronic Precision Manufacturing Ltd (FEI: 3007250267) has 2 FDA import refusal record(s) in our database, spanning from 3/26/2009 to 3/26/2009.
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. Mech Tronic Precision Manufacturing Ltd's FEI number is 3007250267.
What types of violations has Mech Tronic Precision Manufacturing Ltd received?
Mech Tronic Precision Manufacturing 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 Mech Tronic Precision Manufacturing Ltd come from?
All FDA import refusal data for Mech Tronic Precision Manufacturing 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.