Shanghai Medical Instruments Co., Ltd
✅ Low Risk
FEI: 3012562713 • Shanghai, Shanghai • CHINA
FEI Number
3012562713
Location
Shanghai, Shanghai
Country
CHINAAddress
515 Jujiaqiao Road, Pudong New District, Shanghai, Shanghai, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
Frequently Asked Questions
What is Shanghai Medical Instruments Co., Ltd's FDA import refusal history?
Shanghai Medical Instruments Co., Ltd (FEI: 3012562713) has 1 FDA import refusal record(s) in our database, spanning from 11/6/2003 to 11/6/2003.
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. Shanghai Medical Instruments Co., Ltd's FEI number is 3012562713.
What types of violations has Shanghai Medical Instruments Co., Ltd received?
Shanghai Medical Instruments Co., Ltd 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 Shanghai Medical Instruments Co., Ltd come from?
All FDA import refusal data for Shanghai Medical Instruments 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.