Mek Co Ltd Medical Equipment Of Korea
⚠️ Moderate Risk
FEI: 3003898452 • Chunchon • SOUTH KOREA
FEI Number
3003898452
Location
Chunchon
Country
SOUTH KOREAAddress
Industrial Zone 86110 Taegye Dong, , Chunchon, , 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 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 |
|---|---|---|---|
| 9/16/2003 | 74DQAOXIMETER | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 9/16/2003 | 90LWNDEVICE, MEDICAL RADIOGRAPHIC PERSONAL MONITORING | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/15/2003 | 90LWNDEVICE, MEDICAL RADIOGRAPHIC PERSONAL MONITORING | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Mek Co Ltd Medical Equipment Of Korea's FDA import refusal history?
Mek Co Ltd Medical Equipment Of Korea (FEI: 3003898452) has 3 FDA import refusal record(s) in our database, spanning from 3/15/2003 to 9/16/2003.
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. Mek Co Ltd Medical Equipment Of Korea's FEI number is 3003898452.
What types of violations has Mek Co Ltd Medical Equipment Of Korea received?
Mek Co Ltd Medical Equipment Of Korea has been cited for 2 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 Mek Co Ltd Medical Equipment Of Korea come from?
All FDA import refusal data for Mek Co Ltd Medical Equipment Of Korea 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.