Ulrich Gmbh & Co. KG
⚠️ Moderate Risk
FEI: 3002807156 • Ulm, Baden-Wurttemberg • GERMANY
FEI Number
3002807156
Location
Ulm, Baden-Wurttemberg
Country
GERMANYAddress
Buchbrunnenweg 12, , Ulm, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2016 | 87HTXRONGEUR | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/2/2016 | 87LYQACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/2/2016 | 87LYQACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/2/2016 | 87LYQACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/2/2016 | 87LYQACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/2/2016 | 87MAXORTHOSIS, SPINAL INTERVERTEBRAL FUSION | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/2/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/2/2016 | 87HTOREAMER | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/2/2016 | 87LYQACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/2/2016 | 87KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/2/2016 | 87HWJAWL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/2/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/2/2016 | 87LYQACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/2/2016 | 87KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/2/2016 | 87HXKHOLDER, NEEDLE; ORTHOPEDIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/2/2016 | 87HWJAWL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/2/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/5/2005 | 79LRPTRAY, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/5/2005 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/5/2005 | 74MKIGUIDEWIRE, PERIPHERAL ABLATIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/5/2005 | 79GESBLADE, SCALPEL | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ulrich Gmbh & Co. KG's FDA import refusal history?
Ulrich Gmbh & Co. KG (FEI: 3002807156) has 21 FDA import refusal record(s) in our database, spanning from 12/5/2005 to 8/2/2016.
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. Ulrich Gmbh & Co. KG's FEI number is 3002807156.
What types of violations has Ulrich Gmbh & Co. KG received?
Ulrich Gmbh & Co. KG 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 Ulrich Gmbh & Co. KG come from?
All FDA import refusal data for Ulrich Gmbh & Co. KG 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.