Changzhou UNIVERSAL MEDICAL EQUIPMENT CO., LTD
⚠️ Moderate Risk
FEI: 3016710914 • Changzhou, Jiangsu • CHINA
FEI Number
3016710914
Location
Changzhou, Jiangsu
Country
CHINAAddress
No. 6 Xinxi Road, Xinbei District, Changzhou, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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 |
|---|---|---|---|
| 10/6/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/5/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 8/5/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 8/5/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 8/5/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Changzhou UNIVERSAL MEDICAL EQUIPMENT CO., LTD's FDA import refusal history?
Changzhou UNIVERSAL MEDICAL EQUIPMENT CO., LTD (FEI: 3016710914) has 5 FDA import refusal record(s) in our database, spanning from 8/5/2022 to 10/6/2022.
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. Changzhou UNIVERSAL MEDICAL EQUIPMENT CO., LTD's FEI number is 3016710914.
What types of violations has Changzhou UNIVERSAL MEDICAL EQUIPMENT CO., LTD received?
Changzhou UNIVERSAL MEDICAL EQUIPMENT 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 Changzhou UNIVERSAL MEDICAL EQUIPMENT CO., LTD come from?
All FDA import refusal data for Changzhou UNIVERSAL MEDICAL EQUIPMENT 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.