Huvitz Co., Ltd
⚠️ Moderate Risk
FEI: 3003768492 • Anyang, Gyeonggi • SOUTH KOREA
FEI Number
3003768492
Location
Anyang, Gyeonggi
Country
SOUTH KOREAAddress
38, Burim-ro 170beon-gil, Dongan-gu, , Anyang, Gyeonggi, 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.
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 |
|---|---|---|---|
| 11/9/2023 | 86OBOTOMOGRAPHY, OPTICAL COHERENCE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 86OBOTOMOGRAPHY, OPTICAL COHERENCE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 86OBOTOMOGRAPHY, OPTICAL COHERENCE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 86HKXTONOMETER, AC-POWERED | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 86OBOTOMOGRAPHY, OPTICAL COHERENCE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 86OBOTOMOGRAPHY, OPTICAL COHERENCE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 86OBOTOMOGRAPHY, OPTICAL COHERENCE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/18/2002 | 86HOSPROJECTOR, OPHTHALMIC | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 11/18/2002 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 11/18/2002 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Huvitz Co., Ltd's FDA import refusal history?
Huvitz Co., Ltd (FEI: 3003768492) has 10 FDA import refusal record(s) in our database, spanning from 11/18/2002 to 11/9/2023.
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 3003768492.
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.