NINGBO BAICHEN MEDICAL DEVICES CO., LTD
⚠️ High Risk
FEI: 3019842343 • Ningbo, Zhejiang • CHINA
FEI Number
3019842343
Location
Ningbo, Zhejiang
Country
CHINAAddress
Shounan Street Room 903, 666, Taikang Middle Rd; Yinzhou, Ningbo, Zhejiang, 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
3904
3905
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.
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/11/2025 | 89ITIWHEELCHAIR, POWERED | Division of West Coast Imports (DWCI) | |
| 8/8/2025 | 89ITIWHEELCHAIR, POWERED | Division of West Coast Imports (DWCI) | |
| 8/8/2025 | 89ITIWHEELCHAIR, POWERED | Division of West Coast Imports (DWCI) | |
| 8/8/2025 | 89ITIWHEELCHAIR, POWERED | Division of West Coast Imports (DWCI) | |
| 8/8/2025 | 89ITIWHEELCHAIR, POWERED | Division of West Coast Imports (DWCI) | |
| 8/8/2025 | 89ITIWHEELCHAIR, POWERED | Division of West Coast Imports (DWCI) | |
| 7/31/2025 | 89ITIWHEELCHAIR, POWERED | Division of West Coast Imports (DWCI) | |
| 5/8/2025 | 89ITIWHEELCHAIR, POWERED | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 3/19/2025 | 89ITIWHEELCHAIR, POWERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is NINGBO BAICHEN MEDICAL DEVICES CO., LTD's FDA import refusal history?
NINGBO BAICHEN MEDICAL DEVICES CO., LTD (FEI: 3019842343) has 9 FDA import refusal record(s) in our database, spanning from 3/19/2025 to 8/11/2025.
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 BAICHEN MEDICAL DEVICES CO., LTD's FEI number is 3019842343.
What types of violations has NINGBO BAICHEN MEDICAL DEVICES CO., LTD received?
NINGBO BAICHEN MEDICAL DEVICES CO., LTD has been cited for 6 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 BAICHEN MEDICAL DEVICES CO., LTD come from?
All FDA import refusal data for NINGBO BAICHEN 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.