MEDITIME CO., LTD
⚠️ Moderate Risk
FEI: 3016244792 • Wonju, Gangwon • SOUTH KOREA
FEI Number
3016244792
Location
Wonju, Gangwon
Country
SOUTH KOREAAddress
# 605 Medical Complex, 200 Gieopdosi Road, Jieong Myeon, Wonju, Gangwon, 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
3904
3905
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 |
|---|---|---|---|
| 6/11/2025 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of West Coast Imports (DWCI) | |
| 3/19/2025 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of West Coast Imports (DWCI) | |
| 10/8/2024 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of West Coast Imports (DWCI) | |
| 7/1/2024 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of West Coast Imports (DWCI) | |
| 6/10/2024 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | 39043904 | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of West Coast Imports (DWCI) | |
| 3/15/2024 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of West Coast Imports (DWCI) | |
| 3/15/2024 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of West Coast Imports (DWCI) | |
| 3/15/2024 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is MEDITIME CO., LTD's FDA import refusal history?
MEDITIME CO., LTD (FEI: 3016244792) has 9 FDA import refusal record(s) in our database, spanning from 3/15/2024 to 6/11/2025.
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. MEDITIME CO., LTD's FEI number is 3016244792.
What types of violations has MEDITIME CO., LTD received?
MEDITIME CO., LTD has been cited for 4 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.