MiraTes Europe B.V.
⚠️ Moderate Risk
FEI: 3003016870 • Rotterdam, Zuid-Holland • NETHERLANDS
FEI Number
3003016870
Location
Rotterdam, Zuid-Holland
Country
NETHERLANDSAddress
BC 3047, Cairostraat 60, Rotterdam, Zuid-Holland, 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
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 MiraTes Europe B.V.'s FDA import refusal history?
MiraTes Europe B.V. (FEI: 3003016870) has 2 FDA import refusal record(s) in our database, spanning from 1/6/2005 to 1/6/2005.
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. MiraTes Europe B.V.'s FEI number is 3003016870.
What types of violations has MiraTes Europe B.V. received?
MiraTes Europe B.V. has been cited for 1 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 MiraTes Europe B.V. come from?
All FDA import refusal data for MiraTes Europe B.V. 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.