Shenzhen Emperor Electronic Tech
✅ Low Risk
FEI: 3007068035 • Shenzhen • CHINA
FEI Number
3007068035
Location
Shenzhen
Country
CHINAAddress
2&3/F BUILDING 15, NO.1008 SONGBAI ROAD, NANSHAN DISTRICT, Shenzhen, , 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).
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 |
|---|---|---|---|
| 11/17/2011 | 75JJGANALYZER, CHEMISTRY, CENTRIFUGAL, FOR CLINICAL USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/2/2008 | 83JSFCULTURE MEDIA, SINGLE BIOCHEMICAL TEST | Florida District Office (FLA-DO) | |
| 9/2/2008 | 85LQTDOPPLER ULTRASOUND FOR FETAL EVALUATION | Florida District Office (FLA-DO) | |
| 5/27/2004 | 90MUIMEDIA, COUPLING, ULTRASOUND | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Shenzhen Emperor Electronic Tech's FDA import refusal history?
Shenzhen Emperor Electronic Tech (FEI: 3007068035) has 4 FDA import refusal record(s) in our database, spanning from 5/27/2004 to 11/17/2011.
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. Shenzhen Emperor Electronic Tech's FEI number is 3007068035.
What types of violations has Shenzhen Emperor Electronic Tech received?
Shenzhen Emperor Electronic Tech 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 Shenzhen Emperor Electronic Tech come from?
All FDA import refusal data for Shenzhen Emperor Electronic Tech 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.