SOMNOmedics AG
⚠️ Moderate Risk
FEI: 3006258337 • Randersacker, Bavaria • GERMANY
FEI Number
3006258337
Location
Randersacker, Bavaria
Country
GERMANYAddress
Am Sonnenstuhl 63, , Randersacker, Bavaria, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/15/2020 | 84GYBMEDIA, ELECTROCONDUCTIVE | Division of Northern Border Imports (DNBI) | |
| 7/27/2020 | 84GWQELECTROENCEPHALOGRAPH | Division of Southeast Imports (DSEI) | |
| 12/26/2019 | 84GWQELECTROENCEPHALOGRAPH | Division of Northern Border Imports (DNBI) | |
| 1/3/2014 | 74OEDANTIMICROBIAL BLOOD PRESSURE CUFF | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is SOMNOmedics AG's FDA import refusal history?
SOMNOmedics AG (FEI: 3006258337) has 4 FDA import refusal record(s) in our database, spanning from 1/3/2014 to 9/15/2020.
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. SOMNOmedics AG's FEI number is 3006258337.
What types of violations has SOMNOmedics AG received?
SOMNOmedics AG has been cited for 5 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 SOMNOmedics AG come from?
All FDA import refusal data for SOMNOmedics AG 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.