Oxford Medical Instruments Limited
⚠️ Moderate Risk
FEI: 3008177911 • Budakalasz, Pest • HUNGARY
FEI Number
3008177911
Location
Budakalasz, Pest
Country
HUNGARYAddress
Vasut Sor 80, , Budakalasz, Pest, Hungary
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 7/9/2021 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 7/9/2021 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 7/9/2021 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 7/9/2021 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 7/9/2021 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 3/16/2021 | 87LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Oxford Medical Instruments Limited's FDA import refusal history?
Oxford Medical Instruments Limited (FEI: 3008177911) has 6 FDA import refusal record(s) in our database, spanning from 3/16/2021 to 7/9/2021.
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. Oxford Medical Instruments Limited's FEI number is 3008177911.
What types of violations has Oxford Medical Instruments Limited received?
Oxford Medical Instruments Limited has been cited for 3 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 Oxford Medical Instruments Limited come from?
All FDA import refusal data for Oxford Medical Instruments Limited 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.