JIANGSU ALPHAY MEDICAL DEVICE CO
✅ Low Risk
FEI: 3017365177 • Jiangsu • CHINA
FEI Number
3017365177
Location
Jiangsu
Country
CHINAAddress
Mo. 95 Zhen Xing Road, , Jiangsu, , 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
Frequently Asked Questions
What is JIANGSU ALPHAY MEDICAL DEVICE CO's FDA import refusal history?
JIANGSU ALPHAY MEDICAL DEVICE CO (FEI: 3017365177) has 2 FDA import refusal record(s) in our database, spanning from 1/5/2021 to 1/5/2021.
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. JIANGSU ALPHAY MEDICAL DEVICE CO's FEI number is 3017365177.
What types of violations has JIANGSU ALPHAY MEDICAL DEVICE CO received?
JIANGSU ALPHAY MEDICAL DEVICE CO 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 JIANGSU ALPHAY MEDICAL DEVICE CO come from?
All FDA import refusal data for JIANGSU ALPHAY MEDICAL DEVICE 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.