Ningbo Jiangbei Tenso Medical Instruments Co Ltd
⚠️ Moderate Risk
FEI: 3009300054 • Ningbo, zhejiang • CHINA
FEI Number
3009300054
Location
Ningbo, zhejiang
Country
CHINAAddress
No. 3 Xinheng Four Road, CiCheng Private Running Industrial Area, , Ningbo, zhejiang, 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
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/7/2004 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Florida District Office (FLA-DO) | |
| 10/7/2004 | 79FPHGOWN, OPERATING-ROOM | Florida District Office (FLA-DO) | |
| 10/7/2004 | 79KGXTAPE AND BANDAGE, ADHESIVE | Florida District Office (FLA-DO) | |
| 10/7/2004 | 79HAYSPONGE (EXTERNAL USE) | Florida District Office (FLA-DO) | |
| 10/7/2004 | 79GEMGAUZE, ABSORBABLE | Florida District Office (FLA-DO) | |
| 10/7/2004 | 77KCPSYRINGE, ENT | Florida District Office (FLA-DO) | |
| 10/7/2004 | 74DYGCATHETER, FLOW DIRECTED | Florida District Office (FLA-DO) | |
| 10/7/2004 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Florida District Office (FLA-DO) | |
| 10/7/2004 | 79GESBLADE, SCALPEL | Florida District Office (FLA-DO) | |
| 10/7/2004 | 79GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | Florida District Office (FLA-DO) | |
| 10/7/2004 | 85HIBSPECULUM, VAGINAL, NONMETAL | Florida District Office (FLA-DO) | |
| 6/23/2004 | 74KRKMANOMETER, BLOOD-PRESSURE, VENOUS | Florida District Office (FLA-DO) | |
| 2/10/2004 | 74LOSSYSTEM, ECG ANALYSIS, | Division of Southeast Imports (DSEI) | |
| 12/4/2003 | 74DXQCUFF, BLOOD-PRESSURE | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ningbo Jiangbei Tenso Medical Instruments Co Ltd's FDA import refusal history?
Ningbo Jiangbei Tenso Medical Instruments Co Ltd (FEI: 3009300054) has 14 FDA import refusal record(s) in our database, spanning from 12/4/2003 to 10/7/2004.
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 Jiangbei Tenso Medical Instruments Co Ltd's FEI number is 3009300054.
What types of violations has Ningbo Jiangbei Tenso Medical Instruments Co Ltd received?
Ningbo Jiangbei Tenso Medical Instruments Co Ltd has been cited for 3 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 Jiangbei Tenso Medical Instruments Co Ltd come from?
All FDA import refusal data for Ningbo Jiangbei Tenso Medical Instruments 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.