Blue Medical Devices Bv
⚠️ Moderate Risk
FEI: 3003359937 • Helmond, Noord-Brabant • NETHERLANDS
FEI Number
3003359937
Location
Helmond, Noord-Brabant
Country
NETHERLANDSAddress
Steenovenweg 19, , Helmond, Noord-Brabant, Netherlands
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
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).
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 Blue Medical Devices Bv's FDA import refusal history?
Blue Medical Devices Bv (FEI: 3003359937) has 2 FDA import refusal record(s) in our database, spanning from 3/13/2007 to 10/7/2010.
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. Blue Medical Devices Bv's FEI number is 3003359937.
What types of violations has Blue Medical Devices Bv received?
Blue Medical Devices Bv 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 Blue Medical Devices Bv come from?
All FDA import refusal data for Blue 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.