Optimed Medizinische Instrumente GmbH
⚠️ Moderate Risk
FEI: 1000652316 • Ettlingen, Baden-Wurttemberg • GERMANY
FEI Number
1000652316
Location
Ettlingen, Baden-Wurttemberg
Country
GERMANYAddress
Ferdinand-Porsche Str. 13, , Ettlingen, 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).
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).
Refusal History
Frequently Asked Questions
What is Optimed Medizinische Instrumente GmbH's FDA import refusal history?
Optimed Medizinische Instrumente GmbH (FEI: 1000652316) has 1 FDA import refusal record(s) in our database, spanning from 7/24/2006 to 7/24/2006.
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. Optimed Medizinische Instrumente GmbH's FEI number is 1000652316.
What types of violations has Optimed Medizinische Instrumente GmbH received?
Optimed Medizinische Instrumente 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 Optimed Medizinische Instrumente GmbH come from?
All FDA import refusal data for Optimed Medizinische Instrumente 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.