NDI Europe GmbH
⚠️ Moderate Risk
FEI: 3008301410 • Radolfzell am Bodensee, Baden-Wurttemberg • GERMANY
FEI Number
3008301410
Location
Radolfzell am Bodensee, Baden-Wurttemberg
Country
GERMANYAddress
Guttinger Str. 37, , Radolfzell am Bodensee, Baden-Wurttemberg, Germany
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/22/2022 | 85MNBDEVICE, THERMAL ABLATION, ENDOMETRIAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 6/17/2016 | 74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE | Minneapolis District Office (MIN-DO) | |
| 3/28/2013 | 80LDQDEVICE, GENERAL MEDICAL | New England District Office (NWE-DO) | |
| 8/17/2012 | 84HAWINSTRUMENT, STEREOTAXIC | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is NDI Europe GmbH's FDA import refusal history?
NDI Europe GmbH (FEI: 3008301410) has 4 FDA import refusal record(s) in our database, spanning from 8/17/2012 to 9/22/2022.
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. NDI Europe GmbH's FEI number is 3008301410.
What types of violations has NDI Europe GmbH received?
NDI Europe GmbH 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 NDI Europe GmbH come from?
All FDA import refusal data for NDI Europe GmbH 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.