Bricon Technology GmbH
⚠️ Moderate Risk
FEI: 3004072627 • Wurmlingen, Baden-Wurttemberg • GERMANY
FEI Number
3004072627
Location
Wurmlingen, Baden-Wurttemberg
Country
GERMANYAddress
Eisenbahnstr. 100, , Wurmlingen, 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
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).
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).
DEVICE GMP
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2006 | 87MOOORTHOPEDIC IMPLANT MATERIAL | 237NO PMA | New Orleans District Office (NOL-DO) |
| 10/24/2005 | 79LZKIMPLANT, MALAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 11/18/2004 | 87MOOORTHOPEDIC IMPLANT MATERIAL | New Orleans District Office (NOL-DO) | |
| 10/14/2004 | 87JDNIMPLANT, FIXATION DEVICE, SPINAL | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/21/2003 | 87MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE | 226DEVICE GMP | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bricon Technology GmbH's FDA import refusal history?
Bricon Technology GmbH (FEI: 3004072627) has 5 FDA import refusal record(s) in our database, spanning from 11/21/2003 to 7/11/2006.
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. Bricon Technology GmbH's FEI number is 3004072627.
What types of violations has Bricon Technology GmbH received?
Bricon Technology GmbH 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 Bricon Technology GmbH come from?
All FDA import refusal data for Bricon Technology 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.