Brain Products Gmb
⚠️ Moderate Risk
FEI: 3005948695 • Gilching, Bavaria • GERMANY
FEI Number
3005948695
Location
Gilching, Bavaria
Country
GERMANYAddress
Zeppelinstr. 7, , Gilching, 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
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.
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).
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 |
|---|---|---|---|
| 7/31/2012 | 84OBPTRANSCRANIAL MAGNETIC STIMULATOR | New England District Office (NWE-DO) | |
| 7/31/2012 | 84OBPTRANSCRANIAL MAGNETIC STIMULATOR | New England District Office (NWE-DO) | |
| 7/31/2012 | 84OBPTRANSCRANIAL MAGNETIC STIMULATOR | New England District Office (NWE-DO) | |
| 7/31/2012 | 84OBPTRANSCRANIAL MAGNETIC STIMULATOR | New England District Office (NWE-DO) | |
| 7/31/2012 | 84OBPTRANSCRANIAL MAGNETIC STIMULATOR | New England District Office (NWE-DO) | |
| 2/14/2012 | 84NBDSTIMULATOR, CRANIAL, MAGNETIC PULSE (FOR BRAIN MAPPING AND FUNCTION STUDIES) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 2/10/2012 | 84NBDSTIMULATOR, CRANIAL, MAGNETIC PULSE (FOR BRAIN MAPPING AND FUNCTION STUDIES) | New Orleans District Office (NOL-DO) | |
| 12/13/2011 | 84GWQELECTROENCEPHALOGRAPH | New Orleans District Office (NOL-DO) | |
| 9/15/2011 | 84GWQELECTROENCEPHALOGRAPH | New Orleans District Office (NOL-DO) | |
| 11/30/2010 | 84NBDSTIMULATOR, CRANIAL, MAGNETIC PULSE (FOR BRAIN MAPPING AND FUNCTION STUDIES) | 3081INVDEVICE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Brain Products Gmb's FDA import refusal history?
Brain Products Gmb (FEI: 3005948695) has 10 FDA import refusal record(s) in our database, spanning from 11/30/2010 to 7/31/2012.
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. Brain Products Gmb's FEI number is 3005948695.
What types of violations has Brain Products Gmb received?
Brain Products Gmb has been cited for 4 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 Brain Products Gmb come from?
All FDA import refusal data for Brain Products Gmb 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.