IEM GMBH
⚠️ Moderate Risk
FEI: 3018197952 • Aachen • GERMANY
FEI Number
3018197952
Location
Aachen
Country
GERMANYAddress
Gewerbepark Brand 42, , Aachen, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/14/2024 | 74QYFNEONATAL ICU CONTINUOUS NON-INVASIVE BLOOD PRESSURE MONITOR (INCLUDES ALARMS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/14/2024 | 74QYFNEONATAL ICU CONTINUOUS NON-INVASIVE BLOOD PRESSURE MONITOR (INCLUDES ALARMS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/14/2024 | 74QYFNEONATAL ICU CONTINUOUS NON-INVASIVE BLOOD PRESSURE MONITOR (INCLUDES ALARMS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/14/2024 | 74QYFNEONATAL ICU CONTINUOUS NON-INVASIVE BLOOD PRESSURE MONITOR (INCLUDES ALARMS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/14/2024 | 74QYFNEONATAL ICU CONTINUOUS NON-INVASIVE BLOOD PRESSURE MONITOR (INCLUDES ALARMS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is IEM GMBH's FDA import refusal history?
IEM GMBH (FEI: 3018197952) has 5 FDA import refusal record(s) in our database, spanning from 6/14/2024 to 6/14/2024.
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. IEM GMBH's FEI number is 3018197952.
What types of violations has IEM GMBH received?
IEM GMBH has been cited for 1 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 IEM GMBH come from?
All FDA import refusal data for IEM 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.