Jeil Medical Corporation
⚠️ High Risk
FEI: 3004049923 • Seoul • SOUTH KOREA
FEI Number
3004049923
Location
Seoul
Country
SOUTH KOREAAddress
702 Kolon Science Valley 2nd, 55, Digital-ro 34, Guro-gu, Guro-gu, Seoul, , South Korea
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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/9/2022 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Division of Southeast Imports (DSEI) | |
| 5/30/2018 | 76KMWHANDPIECE, ROTARY BONE CUTTING | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Jeil Medical Corporation's FDA import refusal history?
Jeil Medical Corporation (FEI: 3004049923) has 22 FDA import refusal record(s) in our database, spanning from 5/30/2018 to 10/9/2025.
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. Jeil Medical Corporation's FEI number is 3004049923.
What types of violations has Jeil Medical Corporation received?
Jeil Medical Corporation 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 Jeil Medical Corporation come from?
All FDA import refusal data for Jeil Medical Corporation 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.