Signus Medizintechnik GMBH
✅ Low Risk
FEI: 1000615957 • Alzenau, Bavaria • GERMANY
FEI Number
1000615957
Location
Alzenau, Bavaria
Country
GERMANYAddress
Industriestr. 2, , Alzenau, Bavaria, Germany
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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 |
|---|---|---|---|
| 5/7/2007 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/7/2007 | 87HTNWASHER, BOLT, NUT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/7/2007 | 87HRSPLATE, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/7/2007 | 87MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Signus Medizintechnik GMBH's FDA import refusal history?
Signus Medizintechnik GMBH (FEI: 1000615957) has 4 FDA import refusal record(s) in our database, spanning from 5/7/2007 to 5/7/2007.
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. Signus Medizintechnik GMBH's FEI number is 1000615957.
What types of violations has Signus Medizintechnik GMBH received?
Signus Medizintechnik 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 Signus Medizintechnik GMBH come from?
All FDA import refusal data for Signus Medizintechnik 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.