QX World Kft.
⚠️ High Risk
FEI: 3010806878 • Budapest Ix, Budapest • HUNGARY
FEI Number
3010806878
Location
Budapest Ix, Budapest
Country
HUNGARYAddress
Tinodi Utca 1-3/A. Ep. Iv. Em. 93, , Budapest Ix, Budapest, Hungary
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
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 |
|---|---|---|---|
| 11/17/2021 | 84HCCDEVICE, BIOFEEDBACK | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/2/2021 | 84HCCDEVICE, BIOFEEDBACK | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 10/18/2021 | 84HCCDEVICE, BIOFEEDBACK | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 10/15/2021 | 84HCCDEVICE, BIOFEEDBACK | 237NO PMA | Division of Southeast Imports (DSEI) |
| 10/15/2021 | 84HCCDEVICE, BIOFEEDBACK | 237NO PMA | Division of Southeast Imports (DSEI) |
| 10/15/2021 | 84HCCDEVICE, BIOFEEDBACK | 237NO PMA | Division of Southeast Imports (DSEI) |
| 10/15/2021 | 84HCCDEVICE, BIOFEEDBACK | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 84HCCDEVICE, BIOFEEDBACK | Division of Southeast Imports (DSEI) | |
| 3/27/2020 | 84HCCDEVICE, BIOFEEDBACK | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/9/2020 | 84HCCDEVICE, BIOFEEDBACK | 237NO PMA | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is QX World Kft.'s FDA import refusal history?
QX World Kft. (FEI: 3010806878) has 10 FDA import refusal record(s) in our database, spanning from 1/9/2020 to 11/17/2021.
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. QX World Kft.'s FEI number is 3010806878.
What types of violations has QX World Kft. received?
QX World Kft. 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 QX World Kft. come from?
All FDA import refusal data for QX World Kft. 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.