NEUSOFT MEDICAL DEVICES CO., LTD
⚠️ Moderate Risk
FEI: 3012596163 • Shenyang • CHINA
FEI Number
3012596163
Location
Shenyang
Country
CHINAAddress
16 Century Rd Hun Nan, District, Shenyang, , 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).
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
Frequently Asked Questions
What is NEUSOFT MEDICAL DEVICES CO., LTD's FDA import refusal history?
NEUSOFT MEDICAL DEVICES CO., LTD (FEI: 3012596163) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2016 to 11/10/2016.
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. NEUSOFT MEDICAL DEVICES CO., LTD's FEI number is 3012596163.
What types of violations has NEUSOFT MEDICAL DEVICES CO., LTD received?
NEUSOFT MEDICAL DEVICES 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 NEUSOFT MEDICAL DEVICES CO., LTD come from?
All FDA import refusal data for NEUSOFT MEDICAL DEVICES 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.