Medical Econet Co Ltd
⚠️ Moderate Risk
FEI: 3003680759 • Seoul • SOUTH KOREA
FEI Number
3003680759
Location
Seoul
Country
SOUTH KOREAAddress
1004 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
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 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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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 |
|---|---|---|---|
| 4/22/2003 | 97U09ULTRASOUND PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
| 9/19/2002 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Florida District Office (FLA-DO) | |
| 9/19/2002 | 74DRXELECTRODE, ELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 9/19/2002 | 85KXNMONITOR, CARDIAC, FETAL | Florida District Office (FLA-DO) | |
| 9/19/2002 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Florida District Office (FLA-DO) | |
| 7/18/2002 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 7/18/2002 | 85KXNMONITOR, CARDIAC, FETAL | Florida District Office (FLA-DO) | |
| 7/18/2002 | 85LXEFETAL DOPPLER ULTRASOUND | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Medical Econet Co Ltd's FDA import refusal history?
Medical Econet Co Ltd (FEI: 3003680759) has 8 FDA import refusal record(s) in our database, spanning from 7/18/2002 to 4/22/2003.
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. Medical Econet Co Ltd's FEI number is 3003680759.
What types of violations has Medical Econet Co Ltd received?
Medical Econet Co Ltd 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 Medical Econet Co Ltd come from?
All FDA import refusal data for Medical Econet 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.