Langun (Beijing) Electro-Optics Technology Co Ltd
✅ Low Risk
FEI: 3006693796 • Beijing, Beijing • CHINA
FEI Number
3006693796
Location
Beijing, Beijing
Country
CHINAAddress
Hongxing Lou Hongyuan 4 Room 801 A, Jiusiqn Qiao, Beijing, Beijing, 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).
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
Frequently Asked Questions
What is Langun (Beijing) Electro-Optics Technology Co Ltd's FDA import refusal history?
Langun (Beijing) Electro-Optics Technology Co Ltd (FEI: 3006693796) has 2 FDA import refusal record(s) in our database, spanning from 6/25/2008 to 6/25/2008.
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. Langun (Beijing) Electro-Optics Technology Co Ltd's FEI number is 3006693796.
What types of violations has Langun (Beijing) Electro-Optics Technology Co Ltd received?
Langun (Beijing) Electro-Optics Technology Co Ltd has been cited for 3 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 Langun (Beijing) Electro-Optics Technology Co Ltd come from?
All FDA import refusal data for Langun (Beijing) Electro-Optics Technology 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.