SHANGHAI EMAN OPTICAL CO., LTD.
✅ Low Risk
FEI: 3013668097 • Danyang • CHINA
FEI Number
3013668097
Location
Danyang
Country
CHINAAddress
International Optical Center, , Danyang, , 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/16/2017 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is SHANGHAI EMAN OPTICAL CO., LTD.'s FDA import refusal history?
SHANGHAI EMAN OPTICAL CO., LTD. (FEI: 3013668097) has 1 FDA import refusal record(s) in our database, spanning from 8/16/2017 to 8/16/2017.
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 EMAN OPTICAL CO., LTD.'s FEI number is 3013668097.
What types of violations has SHANGHAI EMAN OPTICAL CO., LTD. received?
SHANGHAI EMAN OPTICAL 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 SHANGHAI EMAN OPTICAL CO., LTD. come from?
All FDA import refusal data for SHANGHAI EMAN OPTICAL 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.