EAGELS EQUIPMENT INDUSTRIAL LIMI
⚠️ High Risk
FEI: 3016074271 • Sheung Wan • HONG KONG
FEI Number
3016074271
Location
Sheung Wan
Country
HONG KONGAddress
98 Cheong Tai Commercia, , Sheung Wan, , Hong Kong
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.
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
3905
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 |
|---|---|---|---|
| 9/11/2025 | 79OZCOVER THE COUNTER ACNE TREATMENT | Division of Southeast Imports (DSEI) | |
| 9/11/2025 | 79PAYOVER-THE-COUNTER RADIOFREQUENCY COAGULATION DEVICE FOR WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 6/11/2025 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 12/16/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 12/16/2024 | 89IOBLAMP, INFRARED, PHYSICAL MEDICINE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EAGELS EQUIPMENT INDUSTRIAL LIMI's FDA import refusal history?
EAGELS EQUIPMENT INDUSTRIAL LIMI (FEI: 3016074271) has 5 FDA import refusal record(s) in our database, spanning from 12/16/2024 to 9/11/2025.
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. EAGELS EQUIPMENT INDUSTRIAL LIMI's FEI number is 3016074271.
What types of violations has EAGELS EQUIPMENT INDUSTRIAL LIMI received?
EAGELS EQUIPMENT INDUSTRIAL LIMI 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 EAGELS EQUIPMENT INDUSTRIAL LIMI come from?
All FDA import refusal data for EAGELS EQUIPMENT INDUSTRIAL LIMI 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.