Medison Company Ltd.
⚠️ Moderate Risk
FEI: 3002680904 • Seoul • SOUTH KOREA
FEI Number
3002680904
Location
Seoul
Country
SOUTH KOREAAddress
997-4 Daechi Dong, Kangnam Ku, 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
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 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 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 |
|---|---|---|---|
| 7/13/2006 | 80LDQDEVICE, GENERAL MEDICAL | Division of Southeast Imports (DSEI) | |
| 2/23/2006 | 97U09ULTRASOUND PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
| 6/10/2005 | 74DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC | Florida District Office (FLA-DO) | |
| 1/18/2002 | 74DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION | Florida District Office (FLA-DO) | |
| 12/31/2001 | 90MQBSOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Medison Company Ltd.'s FDA import refusal history?
Medison Company Ltd. (FEI: 3002680904) has 5 FDA import refusal record(s) in our database, spanning from 12/31/2001 to 7/13/2006.
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. Medison Company Ltd.'s FEI number is 3002680904.
What types of violations has Medison Company Ltd. received?
Medison Company Ltd. 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 Medison Company Ltd. come from?
All FDA import refusal data for Medison Company 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.