Vatech Co., Ltd.
✅ Low Risk
FEI: 3004706313 • Hwaseong, Gyeonggi • SOUTH KOREA
FEI Number
3004706313
Location
Hwaseong, Gyeonggi
Country
SOUTH KOREAAddress
13 Samseong1ro2-Gil, , Hwaseong, Gyeonggi, South Korea
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/26/2012 | 76EAPUNIT, X-RAY, INTRAORAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Vatech Co., Ltd.'s FDA import refusal history?
Vatech Co., Ltd. (FEI: 3004706313) has 1 FDA import refusal record(s) in our database, spanning from 4/26/2012 to 4/26/2012.
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. Vatech Co., Ltd.'s FEI number is 3004706313.
What types of violations has Vatech Co., Ltd. received?
Vatech Co., Ltd. has been cited for 1 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 Vatech Co., Ltd. come from?
All FDA import refusal data for Vatech 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.