GUANGDONG BIOLIGHT MEDITECH CO., LTD
⚠️ Moderate Risk
FEI: 3007305624 • Zhuhai, Guangdong • CHINA
FEI Number
3007305624
Location
Zhuhai, Guangdong
Country
CHINAAddress
No.9 Yonghe Road Hi-tech Zone, , Zhuhai, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/18/2022 | 80KMIMONITOR, BED PATIENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/26/2015 | 74DQAOXIMETER | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/13/2013 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 8/11/2011 | 80KMIMONITOR, BED PATIENT | Florida District Office (FLA-DO) | |
| 8/11/2011 | 80KMIMONITOR, BED PATIENT | Florida District Office (FLA-DO) | |
| 1/4/2011 | 80KMIMONITOR, BED PATIENT | Florida District Office (FLA-DO) | |
| 7/14/2010 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 7/14/2010 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is GUANGDONG BIOLIGHT MEDITECH CO., LTD's FDA import refusal history?
GUANGDONG BIOLIGHT MEDITECH CO., LTD (FEI: 3007305624) has 8 FDA import refusal record(s) in our database, spanning from 7/14/2010 to 8/18/2022.
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. GUANGDONG BIOLIGHT MEDITECH CO., LTD's FEI number is 3007305624.
What types of violations has GUANGDONG BIOLIGHT MEDITECH CO., LTD received?
GUANGDONG BIOLIGHT MEDITECH 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 GUANGDONG BIOLIGHT MEDITECH CO., LTD come from?
All FDA import refusal data for GUANGDONG BIOLIGHT MEDITECH 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.