Wuhan Dimed Laser Technology Co., Ltd.
⚠️ High Risk
FEI: 3014577013 • Wuhan, Hubei • CHINA
FEI Number
3014577013
Location
Wuhan, Hubei
Country
CHINAAddress
Room 311, 313, 315, Hubei Guozhi Patent Venture Incubator Building, 327-1 Minzu Avenue,, Wuhan East Lake High-Tech Development Zone, Wuhan, Hubei, 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.
3904
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).
3905
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/10/2025 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 11/6/2025 | 84LLPLASER FOR PAIN THERAPY | Division of West Coast Imports (DWCI) | |
| 6/20/2025 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/6/2024 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of West Coast Imports (DWCI) | |
| 7/1/2024 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Division of West Coast Imports (DWCI) | |
| 11/18/2020 | 79PDZLASERS FOR TEMPORARY INCREASE OF CLEAR NAIL IN PATIENTS WITH ONYCHOMYCOSIS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Wuhan Dimed Laser Technology Co., Ltd.'s FDA import refusal history?
Wuhan Dimed Laser Technology Co., Ltd. (FEI: 3014577013) has 7 FDA import refusal record(s) in our database, spanning from 11/18/2020 to 12/10/2025.
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. Wuhan Dimed Laser Technology Co., Ltd.'s FEI number is 3014577013.
What types of violations has Wuhan Dimed Laser Technology Co., Ltd. received?
Wuhan Dimed Laser Technology Co., Ltd. has been cited for 7 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 Wuhan Dimed Laser Technology Co., Ltd. come from?
All FDA import refusal data for Wuhan Dimed Laser Technology 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.