Sino-Hero (Shenzhen) Bio-Medical Electronics Co,
⚠️ Moderate Risk
FEI: 3009548041 • Shenzhen, Guangdong • CHINA
FEI Number
3009548041
Location
Shenzhen, Guangdong
Country
CHINAAddress
F First Unit 608, 6 Chuangyelu; Nanshan, Shenzhen, Guangdong, 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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2014 | 74LOSSYSTEM, ECG ANALYSIS, | Division of Southeast Imports (DSEI) | |
| 11/21/2013 | 74LOSSYSTEM, ECG ANALYSIS, | Florida District Office (FLA-DO) | |
| 11/21/2013 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Florida District Office (FLA-DO) | |
| 11/21/2013 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | Florida District Office (FLA-DO) | |
| 6/25/2013 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | Division of Southeast Imports (DSEI) | |
| 2/1/2013 | 85LQTDOPPLER ULTRASOUND FOR FETAL EVALUATION | Division of Southeast Imports (DSEI) | |
| 2/1/2013 | 78FIHPUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL | Division of Southeast Imports (DSEI) | |
| 2/1/2013 | 78FIHPUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL | Division of Southeast Imports (DSEI) | |
| 2/1/2013 | 74LOSSYSTEM, ECG ANALYSIS, | Division of Southeast Imports (DSEI) | |
| 2/1/2013 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | Division of Southeast Imports (DSEI) | |
| 7/11/2012 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Sino-Hero (Shenzhen) Bio-Medical Electronics Co,'s FDA import refusal history?
Sino-Hero (Shenzhen) Bio-Medical Electronics Co, (FEI: 3009548041) has 11 FDA import refusal record(s) in our database, spanning from 7/11/2012 to 11/12/2014.
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. Sino-Hero (Shenzhen) Bio-Medical Electronics Co,'s FEI number is 3009548041.
What types of violations has Sino-Hero (Shenzhen) Bio-Medical Electronics Co, received?
Sino-Hero (Shenzhen) Bio-Medical Electronics Co, 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 Sino-Hero (Shenzhen) Bio-Medical Electronics Co, come from?
All FDA import refusal data for Sino-Hero (Shenzhen) Bio-Medical Electronics Co, 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.