Rovers Medical Devices BV
✅ Low Risk
FEI: 1000183403 • Oss, Noord-Brabant • NETHERLANDS
FEI Number
1000183403
Location
Oss, Noord-Brabant
Country
NETHERLANDSAddress
Lekstraat 10, , Oss, Noord-Brabant, Netherlands
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).
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).
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
Frequently Asked Questions
What is Rovers Medical Devices BV's FDA import refusal history?
Rovers Medical Devices BV (FEI: 1000183403) has 1 FDA import refusal record(s) in our database, spanning from 1/27/2003 to 1/27/2003.
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. Rovers Medical Devices BV's FEI number is 1000183403.
What types of violations has Rovers Medical Devices BV received?
Rovers Medical Devices BV 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 Rovers Medical Devices BV come from?
All FDA import refusal data for Rovers Medical Devices BV 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.