NINGBO HANYUE MEDICAL TECHNOLOGYCO.,LTD
⚠️ High Risk
FEI: 3038843651 • Cixi City • CHINA
FEI Number
3038843651
Location
Cixi City
Country
CHINAAddress
No.58 Yugong Road, , Cixi City, , China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2025 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 237NO PMA | Division of Northern Border Imports (DNBI) |
| 10/9/2025 | 77EWTDEVICE, ANTICHOKE, SUCTION | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 10/9/2025 | 80GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED | 508NO 510(K) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is NINGBO HANYUE MEDICAL TECHNOLOGYCO.,LTD's FDA import refusal history?
NINGBO HANYUE MEDICAL TECHNOLOGYCO.,LTD (FEI: 3038843651) has 3 FDA import refusal record(s) in our database, spanning from 10/9/2025 to 10/17/2025.
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. NINGBO HANYUE MEDICAL TECHNOLOGYCO.,LTD's FEI number is 3038843651.
What types of violations has NINGBO HANYUE MEDICAL TECHNOLOGYCO.,LTD received?
NINGBO HANYUE MEDICAL TECHNOLOGYCO.,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 NINGBO HANYUE MEDICAL TECHNOLOGYCO.,LTD come from?
All FDA import refusal data for NINGBO HANYUE MEDICAL TECHNOLOGYCO.,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.