Hanilmeditech Co Ltd
⚠️ Moderate Risk
FEI: 3009740803 • Seoul, Seoul • SOUTH KOREA
FEI Number
3009740803
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
Yonggangdong 2f, , Seoul, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/10/2013 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | New York District Office (NYK-DO) | |
| 1/10/2013 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | New York District Office (NYK-DO) | |
| 1/10/2013 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | New York District Office (NYK-DO) | |
| 1/10/2013 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | New York District Office (NYK-DO) | |
| 1/10/2013 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | New York District Office (NYK-DO) | |
| 1/10/2013 | 89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | New York District Office (NYK-DO) | |
| 1/10/2013 | 79KDDKIT, SURGICAL INSTRUMENT, DISPOSABLE | New York District Office (NYK-DO) | |
| 1/10/2013 | 79OYWFOR THE REMOVAL OF FAT THROUGH LASER LIPOLYSIS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Hanilmeditech Co Ltd's FDA import refusal history?
Hanilmeditech Co Ltd (FEI: 3009740803) has 8 FDA import refusal record(s) in our database, spanning from 1/10/2013 to 1/10/2013.
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. Hanilmeditech Co Ltd's FEI number is 3009740803.
What types of violations has Hanilmeditech Co Ltd received?
Hanilmeditech Co 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 Hanilmeditech Co Ltd come from?
All FDA import refusal data for Hanilmeditech 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.