Unimed Medical Supplies Inc
⚠️ High Risk
FEI: 3007307487 • Shenzhen, Guangdong • CHINA
FEI Number
3007307487
Location
Shenzhen, Guangdong
Country
CHINAAddress
Bldg. 8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan, Shenzhen, Guangdong, 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
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.
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2025 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/1/2025 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/1/2025 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/5/2023 | 74DXQCUFF, BLOOD-PRESSURE | Division of Northern Border Imports (DNBI) | |
| 12/5/2023 | 74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | Division of Northern Border Imports (DNBI) | |
| 3/22/2023 | 74DXQCUFF, BLOOD-PRESSURE | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 11/16/2022 | 73DQAOXIMETER | Division of West Coast Imports (DWCI) | |
| 11/16/2022 | 73DQAOXIMETER | Division of West Coast Imports (DWCI) | |
| 9/30/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/22/2022 | 74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | Division of Southeast Imports (DSEI) | |
| 5/18/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 4/29/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/29/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/29/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/28/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/22/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/20/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/6/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/6/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/1/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/31/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/18/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/15/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/14/2022 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/23/2019 | 74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 5/23/2017 | 73DQAOXIMETER | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 5/23/2017 | 73DQAOXIMETER | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 5/23/2017 | 73DQAOXIMETER | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 10/16/2014 | 74DQAOXIMETER | 508NO 510(K) | Detroit District Office (DET-DO) |
| 10/17/2013 | 74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | 341REGISTERED | Seattle District Office (SEA-DO) |
| 10/17/2013 | 73DQAOXIMETER | 341REGISTERED | Seattle District Office (SEA-DO) |
| 10/2/2013 | 74DQAOXIMETER | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Unimed Medical Supplies Inc's FDA import refusal history?
Unimed Medical Supplies Inc (FEI: 3007307487) has 34 FDA import refusal record(s) in our database, spanning from 10/2/2013 to 12/9/2025.
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. Unimed Medical Supplies Inc's FEI number is 3007307487.
What types of violations has Unimed Medical Supplies Inc received?
Unimed Medical Supplies Inc has been cited for 6 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 Unimed Medical Supplies Inc come from?
All FDA import refusal data for Unimed Medical Supplies Inc 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.