Meditime Co Ltd
⚠️ Moderate Risk
FEI: 3009814336 • Yong-in • SOUTH KOREA
FEI Number
3009814336
Location
Yong-in
Country
SOUTH KOREAAddress
476-112 Gongse-Dong, Giheung-Gu, , Yong-in, , 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
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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 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).
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/25/2013 | 95RHMIMAGE DIGITIZER | Los Angeles District Office (LOS-DO) | |
| 3/25/2013 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Los Angeles District Office (LOS-DO) | |
| 3/25/2013 | 89NHNLAMP, NON-HEATING, FOR ADJUNCTIVE USE IN PAIN THERAPY | Los Angeles District Office (LOS-DO) | |
| 3/25/2013 | 79OUHSKIN RESURFACING RF APPLICATOR | Los Angeles District Office (LOS-DO) | |
| 3/25/2013 | 79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION | Los Angeles District Office (LOS-DO) | |
| 3/25/2013 | 79JCXAPPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Meditime Co Ltd's FDA import refusal history?
Meditime Co Ltd (FEI: 3009814336) has 6 FDA import refusal record(s) in our database, spanning from 3/25/2013 to 3/25/2013.
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. Meditime Co Ltd's FEI number is 3009814336.
What types of violations has Meditime Co Ltd received?
Meditime Co Ltd has been cited for 9 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 Meditime Co Ltd come from?
All FDA import refusal data for Meditime 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.