HANGZHOU FUSHAN MEDICAL APPLIANCES CO.,LTD
⚠️ Moderate Risk
FEI: 3006787036 • Hangzhou, Zhejiang • CHINA
FEI Number
3006787036
Location
Hangzhou, Zhejiang
Country
CHINAAddress
1288 South Jinxi Road, Linglong Industr, Linan, Hangzhou, 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
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).
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/21/2021 | 80KMKDEVICE, INTRAVASCULAR CATHETER SECUREMENT | Division of Southeast Imports (DSEI) | |
| 2/19/2020 | 78EYZSYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER | Division of Northern Border Imports (DNBI) | |
| 11/16/2015 | 78EYZSYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER | Los Angeles District Office (LOS-DO) | |
| 5/23/2014 | 79OTKWOUND DRAIN CATHETER SYSTEM | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 5/23/2014 | 79OTKWOUND DRAIN CATHETER SYSTEM | 341REGISTERED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is HANGZHOU FUSHAN MEDICAL APPLIANCES CO.,LTD's FDA import refusal history?
HANGZHOU FUSHAN MEDICAL APPLIANCES CO.,LTD (FEI: 3006787036) has 5 FDA import refusal record(s) in our database, spanning from 5/23/2014 to 7/21/2021.
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. HANGZHOU FUSHAN MEDICAL APPLIANCES CO.,LTD's FEI number is 3006787036.
What types of violations has HANGZHOU FUSHAN MEDICAL APPLIANCES CO.,LTD received?
HANGZHOU FUSHAN MEDICAL APPLIANCES CO.,LTD has been cited for 5 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 HANGZHOU FUSHAN MEDICAL APPLIANCES CO.,LTD come from?
All FDA import refusal data for HANGZHOU FUSHAN MEDICAL APPLIANCES 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.