CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY
⚠️ Moderate Risk
FEI: 3014607444 • Suzhou, Jiangsu • CHINA
FEI Number
3014607444
Location
Suzhou, Jiangsu
Country
CHINAAddress
Furongcun, Gulizhen Changshu, Suzhou, Jiangsu, 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2019 | 78KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/23/2010 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/19/2005 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | Division of West Coast Imports (DWCI) | |
| 10/19/2005 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | Division of West Coast Imports (DWCI) | |
| 10/19/2005 | 78FFGDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 80JOLCATHETER AND TIP, SUCTION | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 80JOLCATHETER AND TIP, SUCTION | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/19/2005 | 78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/19/2005 | 78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 8/4/2005 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 8/4/2005 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY's FDA import refusal history?
CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY (FEI: 3014607444) has 19 FDA import refusal record(s) in our database, spanning from 8/4/2005 to 5/24/2019.
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. CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY's FEI number is 3014607444.
What types of violations has CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY received?
CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY 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 CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY come from?
All FDA import refusal data for CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY 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.