Merhua Medical Devices Co Lyd
✅ Low Risk
FEI: 3005768909 • Shanghai, Shanghai • CHINA
FEI Number
3005768909
Location
Shanghai, Shanghai
Country
CHINAAddress
688 Heng Jiang Road, , Shanghai, Shanghai, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/14/2006 | 85HDFSPECULUM, VAGINAL, METAL | 118NOT LISTED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Merhua Medical Devices Co Lyd's FDA import refusal history?
Merhua Medical Devices Co Lyd (FEI: 3005768909) has 1 FDA import refusal record(s) in our database, spanning from 7/14/2006 to 7/14/2006.
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. Merhua Medical Devices Co Lyd's FEI number is 3005768909.
What types of violations has Merhua Medical Devices Co Lyd received?
Merhua Medical Devices Co Lyd has been cited for 1 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 Merhua Medical Devices Co Lyd come from?
All FDA import refusal data for Merhua Medical Devices Co Lyd 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.