Wuxi Ea Medical Instruments Technologies Limited
✅ Low Risk
FEI: 3013556527 • Wuxi City, JIANGSU • CHINA
FEI Number
3013556527
Location
Wuxi City, JIANGSU
Country
CHINAAddress
1F, No. 2 Building, No. 1619 Huishan Ave, , Wuxi City, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 Wuxi Ea Medical Instruments Technologies Limited's FDA import refusal history?
Wuxi Ea Medical Instruments Technologies Limited (FEI: 3013556527) has 1 FDA import refusal record(s) in our database, spanning from 11/18/2022 to 11/18/2022.
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. Wuxi Ea Medical Instruments Technologies Limited's FEI number is 3013556527.
What types of violations has Wuxi Ea Medical Instruments Technologies Limited received?
Wuxi Ea Medical Instruments Technologies Limited has been cited for 2 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 Wuxi Ea Medical Instruments Technologies Limited come from?
All FDA import refusal data for Wuxi Ea Medical Instruments Technologies Limited 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.