Sino Hero Bio Medical Electronic
⚠️ Moderate Risk
FEI: 3008487487 • Shenzhenshi, Yandongsheng • CHINA
FEI Number
3008487487
Location
Shenzhenshi, Yandongsheng
Country
CHINAAddress
A Block F Unit 901 9 Nanhaidadao, , Shenzhenshi, Yandongsheng, 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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
Frequently Asked Questions
What is Sino Hero Bio Medical Electronic's FDA import refusal history?
Sino Hero Bio Medical Electronic (FEI: 3008487487) has 1 FDA import refusal record(s) in our database, spanning from 9/14/2010 to 9/14/2010.
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 Bio Medical Electronic's FEI number is 3008487487.
What types of violations has Sino Hero Bio Medical Electronic received?
Sino Hero Bio Medical Electronic 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 Sino Hero Bio Medical Electronic come from?
All FDA import refusal data for Sino Hero Bio Medical Electronic 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.