SAMSUNG MEDISON
⚠️ Moderate Risk
FEI: 3035363492 • Seoul • SOUTH KOREA
FEI Number
3035363492
Location
Seoul
Country
SOUTH KOREAAddress
East Central Tower 1077cheonho-Daero, , Seoul, , South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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).
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 |
|---|---|---|---|
| 3/11/2025 | 90LXEDOPPLER, FETAL, ULTRASOUND | Division of West Coast Imports (DWCI) | |
| 3/11/2025 | 90LXEDOPPLER, FETAL, ULTRASOUND | Division of West Coast Imports (DWCI) | |
| 3/11/2025 | 90LXEDOPPLER, FETAL, ULTRASOUND | Division of West Coast Imports (DWCI) | |
| 3/11/2025 | 90LXEDOPPLER, FETAL, ULTRASOUND | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is SAMSUNG MEDISON's FDA import refusal history?
SAMSUNG MEDISON (FEI: 3035363492) has 4 FDA import refusal record(s) in our database, spanning from 3/11/2025 to 3/11/2025.
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. SAMSUNG MEDISON's FEI number is 3035363492.
What types of violations has SAMSUNG MEDISON received?
SAMSUNG MEDISON 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 SAMSUNG MEDISON come from?
All FDA import refusal data for SAMSUNG MEDISON 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.