FUZHOU MEIRUN MEDICAL DEVICE TEC
✅ Low Risk
FEI: 3017113959 • Fuzhou • CHINA
FEI Number
3017113959
Location
Fuzhou
Country
CHINAAddress
Baiyue Cultural Village, Hecheng, Fuzhou, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/11/2020 | 80PXHTHERMOMETER KIT | 341REGISTERED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is FUZHOU MEIRUN MEDICAL DEVICE TEC's FDA import refusal history?
FUZHOU MEIRUN MEDICAL DEVICE TEC (FEI: 3017113959) has 1 FDA import refusal record(s) in our database, spanning from 8/11/2020 to 8/11/2020.
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. FUZHOU MEIRUN MEDICAL DEVICE TEC's FEI number is 3017113959.
What types of violations has FUZHOU MEIRUN MEDICAL DEVICE TEC received?
FUZHOU MEIRUN MEDICAL DEVICE TEC 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 FUZHOU MEIRUN MEDICAL DEVICE TEC come from?
All FDA import refusal data for FUZHOU MEIRUN MEDICAL DEVICE TEC 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.