EMA AESTHETIC LIMITED
⚠️ High Risk
FEI: 3021177911 • Dublin • IRELAND
FEI Number
3021177911
Location
Dublin
Country
IRELANDAddress
Palmerston House, Fenian Street, Dublin, , Ireland
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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/19/2025 | 79GFEBRUSH, DERMABRASION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/18/2025 | 79PBXMASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/8/2025 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/8/2025 | 79GFEBRUSH, DERMABRASION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/23/2025 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/23/2025 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/9/2025 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 7/9/2025 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 7/9/2025 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 12/5/2024 | 79GFEBRUSH, DERMABRASION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/5/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/5/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EMA AESTHETIC LIMITED's FDA import refusal history?
EMA AESTHETIC LIMITED (FEI: 3021177911) has 12 FDA import refusal record(s) in our database, spanning from 12/5/2024 to 8/19/2025.
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. EMA AESTHETIC LIMITED's FEI number is 3021177911.
What types of violations has EMA AESTHETIC LIMITED received?
EMA AESTHETIC LIMITED has been cited for 3 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 EMA AESTHETIC LIMITED come from?
All FDA import refusal data for EMA AESTHETIC 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.