Inomed Medizintechnik Gmbh
⚠️ Moderate Risk
FEI: 3008479103 • Emmendingen, Baden-Wurttemberg • GERMANY
FEI Number
3008479103
Location
Emmendingen, Baden-Wurttemberg
Country
GERMANYAddress
Im Hausgrun 29, , Emmendingen, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/3/2021 | 84GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE | Division of West Coast Imports (DWCI) | |
| 5/3/2021 | 84GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE | Division of West Coast Imports (DWCI) | |
| 5/3/2021 | 84GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Inomed Medizintechnik Gmbh's FDA import refusal history?
Inomed Medizintechnik Gmbh (FEI: 3008479103) has 3 FDA import refusal record(s) in our database, spanning from 5/3/2021 to 5/3/2021.
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. Inomed Medizintechnik Gmbh's FEI number is 3008479103.
What types of violations has Inomed Medizintechnik Gmbh received?
Inomed Medizintechnik Gmbh 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 Inomed Medizintechnik Gmbh come from?
All FDA import refusal data for Inomed Medizintechnik 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.