GE Medical Systems Information Technologies Gmbh
⚠️ Moderate Risk
FEI: 3002807162 • Freiburg im Breisgau, Baden-Wurttemberg • GERMANY
FEI Number
3002807162
Location
Freiburg im Breisgau, Baden-Wurttemberg
Country
GERMANYAddress
Munzinger Str. 3, , Freiburg im Breisgau, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/23/2022 | 84GXYELECTRODE, CUTANEOUS | Division of Southwest Imports (DSWI) | |
| 3/23/2022 | 85HELMONITOR, HEART RATE, FETAL, ULTRASONIC | Division of Southwest Imports (DSWI) | |
| 3/23/2022 | 85HELMONITOR, HEART RATE, FETAL, ULTRASONIC | Division of Southwest Imports (DSWI) | |
| 4/25/2002 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is GE Medical Systems Information Technologies Gmbh's FDA import refusal history?
GE Medical Systems Information Technologies Gmbh (FEI: 3002807162) has 4 FDA import refusal record(s) in our database, spanning from 4/25/2002 to 3/23/2022.
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. GE Medical Systems Information Technologies Gmbh's FEI number is 3002807162.
What types of violations has GE Medical Systems Information Technologies Gmbh received?
GE Medical Systems Information Technologies Gmbh has been cited for 3 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 GE Medical Systems Information Technologies Gmbh come from?
All FDA import refusal data for GE Medical Systems Information Technologies 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.