Beijing Choice Electronic Technology Co., Ltd.
⚠️ Moderate Risk
FEI: 3005569927 • Beijing, Beijing • CHINA
FEI Number
3005569927
Location
Beijing, Beijing
Country
CHINAAddress
No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District, Beijing, Beijing, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/5/2021 | 73DQAOXIMETER | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 1/5/2021 | 73DQAOXIMETER | Division of West Coast Imports (DWCI) | |
| 1/5/2021 | 73DQAOXIMETER | Division of West Coast Imports (DWCI) | |
| 10/2/2015 | 73DQAOXIMETER | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 7/19/2011 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 6/9/2011 | 80KMIMONITOR, BED PATIENT | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/6/2011 | 73DQAOXIMETER | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 12/2/2010 | 74LOSSYSTEM, ECG ANALYSIS, | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 12/2/2010 | 74LOSSYSTEM, ECG ANALYSIS, | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 7/8/2010 | 80KMIMONITOR, BED PATIENT | Florida District Office (FLA-DO) | |
| 1/14/2010 | 89IPSCANE | Los Angeles District Office (LOS-DO) | |
| 1/14/2010 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) | |
| 1/14/2010 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) | |
| 10/1/2009 | 74DQAOXIMETER | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Beijing Choice Electronic Technology Co., Ltd.'s FDA import refusal history?
Beijing Choice Electronic Technology Co., Ltd. (FEI: 3005569927) has 14 FDA import refusal record(s) in our database, spanning from 10/1/2009 to 1/5/2021.
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. Beijing Choice Electronic Technology Co., Ltd.'s FEI number is 3005569927.
What types of violations has Beijing Choice Electronic Technology Co., Ltd. received?
Beijing Choice Electronic 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 Beijing Choice Electronic Technology Co., Ltd. come from?
All FDA import refusal data for Beijing Choice Electronic 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.