Lingen Precision Medical Products (Shanghai) Co., Ltd
✅ Low Risk
FEI: 3013649343 • Shanghai, Shanghai • CHINA
FEI Number
3013649343
Location
Shanghai, Shanghai
Country
CHINAAddress
No. 59 Yewang Road, Ye, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/2/2020 | 80NNICONTAINER, SPECIMEN, NON-STERILE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Lingen Precision Medical Products (Shanghai) Co., Ltd's FDA import refusal history?
Lingen Precision Medical Products (Shanghai) Co., Ltd (FEI: 3013649343) has 1 FDA import refusal record(s) in our database, spanning from 7/2/2020 to 7/2/2020.
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. Lingen Precision Medical Products (Shanghai) Co., Ltd's FEI number is 3013649343.
What types of violations has Lingen Precision Medical Products (Shanghai) Co., Ltd received?
Lingen Precision Medical Products (Shanghai) 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 Lingen Precision Medical Products (Shanghai) Co., Ltd come from?
All FDA import refusal data for Lingen Precision Medical Products (Shanghai) 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.