SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD
⚠️ Moderate Risk
FEI: 3007865190 • Shenzhnsh, Yandong • CHINA
FEI Number
3007865190
Location
Shenzhnsh, Yandong
Country
CHINAAddress
Building 2 Huafanlu, Dalang Longhua Baoan, Shenzhnsh, Yandong, 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
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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 |
|---|---|---|---|
| 12/4/2014 | 74DXQCUFF, BLOOD-PRESSURE | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 12/4/2014 | 74DXQCUFF, BLOOD-PRESSURE | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 12/4/2014 | 74DXQCUFF, BLOOD-PRESSURE | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 12/4/2014 | 74DXQCUFF, BLOOD-PRESSURE | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 12/4/2014 | 74DXQCUFF, BLOOD-PRESSURE | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 12/4/2014 | 74DXQCUFF, BLOOD-PRESSURE | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 12/4/2014 | 74DXQCUFF, BLOOD-PRESSURE | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 12/4/2014 | 74DXQCUFF, BLOOD-PRESSURE | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 5/22/2013 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) | |
| 5/22/2013 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) | |
| 5/22/2013 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) | |
| 5/22/2013 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) | |
| 5/22/2013 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) | |
| 5/22/2013 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) | |
| 5/22/2013 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) | |
| 5/22/2013 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) | |
| 5/22/2013 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) | |
| 5/22/2013 | 74DQAOXIMETER | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD's FDA import refusal history?
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD (FEI: 3007865190) has 18 FDA import refusal record(s) in our database, spanning from 5/22/2013 to 12/4/2014.
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 MED-LINK ELECTRONICS TECH CO., LTD's FEI number is 3007865190.
What types of violations has SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD received?
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD has been cited for 4 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 MED-LINK ELECTRONICS TECH CO., LTD come from?
All FDA import refusal data for SHENZHEN MED-LINK ELECTRONICS TECH 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.