EDMUND OPTICS SHENZHEN LTD.
⚠️ High Risk
FEI: 3015220923 • Shenzhen • CHINA
FEI Number
3015220923
Location
Shenzhen
Country
CHINAAddress
Scientific & Industrial Park, (Spb)(L3p)5/F Block 3 Luck-King, Shenzhen, , China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Division of Southeast Imports (DSEI) | |
| 9/24/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EDMUND OPTICS SHENZHEN LTD.'s FDA import refusal history?
EDMUND OPTICS SHENZHEN LTD. (FEI: 3015220923) has 3 FDA import refusal record(s) in our database, spanning from 9/24/2025 to 9/24/2025.
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. EDMUND OPTICS SHENZHEN LTD.'s FEI number is 3015220923.
What types of violations has EDMUND OPTICS SHENZHEN LTD. received?
EDMUND OPTICS SHENZHEN 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 EDMUND OPTICS SHENZHEN LTD. come from?
All FDA import refusal data for EDMUND OPTICS SHENZHEN 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.