Jiangyin Binjiang Medical Equipment Co., Ltd.
✅ Low Risk
FEI: 3007092199 • Jiangyin City • CHINA
FEI Number
3007092199
Location
Jiangyin City
Country
CHINAAddress
Eastern Area of Chengjiang Town, Industrial Park, Jiangyin City, , 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).
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
Frequently Asked Questions
What is Jiangyin Binjiang Medical Equipment Co., Ltd.'s FDA import refusal history?
Jiangyin Binjiang Medical Equipment Co., Ltd. (FEI: 3007092199) has 2 FDA import refusal record(s) in our database, spanning from 9/5/2008 to 12/2/2008.
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. Jiangyin Binjiang Medical Equipment Co., Ltd.'s FEI number is 3007092199.
What types of violations has Jiangyin Binjiang Medical Equipment Co., Ltd. received?
Jiangyin Binjiang Medical Equipment Co., Ltd. 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 Jiangyin Binjiang Medical Equipment Co., Ltd. come from?
All FDA import refusal data for Jiangyin Binjiang Medical Equipment 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.