HUVITZ CO.,LTD
⚠️ Moderate Risk
FEI: 3012859058 • Gunpo • SOUTH KOREA
FEI Number
3012859058
Location
Gunpo
Country
SOUTH KOREAAddress
298-29 Gumjeong-dong, , Gunpo, , 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/14/2023 | 86OBOTOMOGRAPHY, OPTICAL COHERENCE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/21/2020 | 86OBOTOMOGRAPHY, OPTICAL COHERENCE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/25/2019 | 86HKXTONOMETER, AC-POWERED | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/12/2018 | 86HKXTONOMETER, AC-POWERED | 237NO PMA | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HUVITZ CO.,LTD's FDA import refusal history?
HUVITZ CO.,LTD (FEI: 3012859058) has 4 FDA import refusal record(s) in our database, spanning from 3/12/2018 to 2/14/2023.
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. HUVITZ CO.,LTD's FEI number is 3012859058.
What types of violations has HUVITZ CO.,LTD received?
HUVITZ CO.,LTD has been cited for 2 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 HUVITZ CO.,LTD come from?
All FDA import refusal data for HUVITZ 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.