SHAOXING UNDIS MEDICAL TECHNOLOGY C
⚠️ High Risk
FEI: 3016523578 • Shaoxing, Zhejiang • CHINA
FEI Number
3016523578
Location
Shaoxing, Zhejiang
Country
CHINAAddress
Yuexing Technology Park No.12, No. 11 Binhai Huayuan; Lihaizhen Shangyu, Shaoxing, Zhejiang, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/30/2024 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | Division of Southeast Imports (DSEI) | |
| 9/30/2024 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | Division of Southeast Imports (DSEI) | |
| 9/30/2024 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | Division of Southeast Imports (DSEI) | |
| 9/30/2024 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | Division of Southeast Imports (DSEI) | |
| 9/30/2024 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | Division of Southeast Imports (DSEI) | |
| 9/30/2024 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | Division of Southeast Imports (DSEI) | |
| 9/30/2024 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | Division of Southeast Imports (DSEI) | |
| 9/30/2024 | 73BSJMASK, GAS, ANESTHETIC | Division of Southeast Imports (DSEI) | |
| 9/30/2024 | 73BTCBAG, RESERVOIR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHAOXING UNDIS MEDICAL TECHNOLOGY C's FDA import refusal history?
SHAOXING UNDIS MEDICAL TECHNOLOGY C (FEI: 3016523578) has 9 FDA import refusal record(s) in our database, spanning from 9/30/2024 to 9/30/2024.
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. SHAOXING UNDIS MEDICAL TECHNOLOGY C's FEI number is 3016523578.
What types of violations has SHAOXING UNDIS MEDICAL TECHNOLOGY C received?
SHAOXING UNDIS MEDICAL TECHNOLOGY C 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 SHAOXING UNDIS MEDICAL TECHNOLOGY C come from?
All FDA import refusal data for SHAOXING UNDIS MEDICAL TECHNOLOGY C 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.