Conod Medical Co., Limited
⚠️ High Risk
FEI: 3005596530 • Suzhou, Jiangsu • CHINA
FEI Number
3005596530
Location
Suzhou, Jiangsu
Country
CHINAAddress
# 38 Zifu Shequ, Gulizhen Changshu, Suzhou, Jiangsu, 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).
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/18/2025 | 78SCTFOLEY CATHETERS AND ACCESSORIES WITH ADDITIONAL SAFETY FEATURES | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 3/26/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 3/26/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 3/26/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 3/26/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 3/26/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 3/26/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 3/26/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 3/26/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 7/14/2016 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/14/2016 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/14/2016 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/14/2016 | 78EZLCATHETER, RETENTION TYPE, BALLOON | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/14/2016 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/14/2016 | 78FHXJELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/14/2016 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/14/2016 | 78EZLCATHETER, RETENTION TYPE, BALLOON | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 4/8/2010 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | Los Angeles District Office (LOS-DO) | |
| 3/23/2010 | 79KDDKIT, SURGICAL INSTRUMENT, DISPOSABLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/23/2010 | 79LRPTRAY, SURGICAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/23/2010 | 78FCMTRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Conod Medical Co., Limited's FDA import refusal history?
Conod Medical Co., Limited (FEI: 3005596530) has 21 FDA import refusal record(s) in our database, spanning from 3/23/2010 to 11/18/2025.
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. Conod Medical Co., Limited's FEI number is 3005596530.
What types of violations has Conod Medical Co., Limited received?
Conod Medical Co., Limited has been cited for 4 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 Conod Medical Co., Limited come from?
All FDA import refusal data for Conod Medical Co., Limited 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.