Ziehm Imaging Gmbh
⚠️ Moderate Risk
FEI: 3005430103 • Nuremberg, Bavaria • GERMANY
FEI Number
3005430103
Location
Nuremberg, Bavaria
Country
GERMANYAddress
Nuernberg, Lina-Ammon-Str. 10, Nuremberg, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/2/2023 | 90EHBCOLLIMATOR, X-RAY | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 3/2/2023 | 90EHBCOLLIMATOR, X-RAY | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 3/2/2023 | 90EHBCOLLIMATOR, X-RAY | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/28/2015 | 90JABSYSTEM, X-RAY, FLUOROSCOPIC, NON-IMAGE-INTENSIFIED | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/28/2015 | 90JABSYSTEM, X-RAY, FLUOROSCOPIC, NON-IMAGE-INTENSIFIED | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ziehm Imaging Gmbh's FDA import refusal history?
Ziehm Imaging Gmbh (FEI: 3005430103) has 5 FDA import refusal record(s) in our database, spanning from 9/28/2015 to 3/2/2023.
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. Ziehm Imaging Gmbh's FEI number is 3005430103.
What types of violations has Ziehm Imaging Gmbh received?
Ziehm Imaging 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 Ziehm Imaging Gmbh come from?
All FDA import refusal data for Ziehm Imaging 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.