Brainlab SE
⚠️ Moderate Risk
FEI: 3002619595 • Munich, Bavaria • GERMANY
FEI Number
3002619595
Location
Munich, Bavaria
Country
GERMANYAddress
Olof-Palme-Str. 9, , Munich, 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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/2/2014 | 90LHNSYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL | Division of Southeast Imports (DSEI) | |
| 12/2/2014 | 90MUJSYSTEM, PLANNING, RADIATION THERAPY TREATMENT | Division of Southeast Imports (DSEI) | |
| 5/7/2007 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 1/10/2007 | 84LKWLASER, NEUROSURGICAL | Chicago District Office (CHI-DO) | |
| 10/24/2005 | 79NRJULTRASOUND, SKIN PERMEATION | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 10/21/2005 | 79DWONEEDLE, BIOPSY, CARDIOVASCULAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/23/2005 | 87HWCSCREW, FIXATION, BONE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 9/12/2003 | 94N14ANALYTICAL X-RAY SYSTEM OR COMPONENT FOR NON-MEDICAL USE | 476NO REGISTR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Brainlab SE's FDA import refusal history?
Brainlab SE (FEI: 3002619595) has 8 FDA import refusal record(s) in our database, spanning from 9/12/2003 to 12/2/2014.
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. Brainlab SE's FEI number is 3002619595.
What types of violations has Brainlab SE received?
Brainlab SE has been cited for 6 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 Brainlab SE come from?
All FDA import refusal data for Brainlab SE 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.