Ningbo Joycare Medical Instrumen
⚠️ Moderate Risk
FEI: 3011802841 • Ningbo • CHINA
FEI Number
3011802841
Location
Ningbo
Country
CHINAAddress
2902 Huiya Int 1107 North Tianto, , Ningbo, , 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/28/2015 | 78FEZCATHETER AND TUBE, SUPRAPUBIC | Division of Southeast Imports (DSEI) | |
| 10/28/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) | |
| 10/28/2015 | 78KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | Division of Southeast Imports (DSEI) | |
| 10/28/2015 | 78KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | Division of Southeast Imports (DSEI) | |
| 10/28/2015 | 80FQMBANDAGE, ELASTIC | Division of Southeast Imports (DSEI) | |
| 10/28/2015 | 80FQMBANDAGE, ELASTIC | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ningbo Joycare Medical Instrumen's FDA import refusal history?
Ningbo Joycare Medical Instrumen (FEI: 3011802841) has 6 FDA import refusal record(s) in our database, spanning from 10/28/2015 to 10/28/2015.
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 Joycare Medical Instrumen's FEI number is 3011802841.
What types of violations has Ningbo Joycare Medical Instrumen received?
Ningbo Joycare Medical Instrumen 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 Joycare Medical Instrumen come from?
All FDA import refusal data for Ningbo Joycare Medical Instrumen 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.