Ilo Electronic
⚠️ Moderate Risk
FEI: 3001584149 • Quickborn, Schleswig-Holstein • GERMANY
FEI Number
3001584149
Location
Quickborn, Schleswig-Holstein
Country
GERMANYAddress
Carl-Zeiss-Str. 3, , Quickborn, Schleswig-Holstein, 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).
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 |
|---|---|---|---|
| 1/12/2005 | 78FEBACCESSORIES, CLEANING, FOR ENDOSCOPE | Division of Southeast Imports (DSEI) | |
| 1/12/2005 | 78GCTLIGHT SOURCE, ENDOSCOPE, XENON ARC | Division of Southeast Imports (DSEI) | |
| 1/12/2005 | 78FCXINSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE | Division of Southeast Imports (DSEI) | |
| 12/6/2001 | 75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ilo Electronic's FDA import refusal history?
Ilo Electronic (FEI: 3001584149) has 4 FDA import refusal record(s) in our database, spanning from 12/6/2001 to 1/12/2005.
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. Ilo Electronic's FEI number is 3001584149.
What types of violations has Ilo Electronic received?
Ilo Electronic 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 Ilo Electronic come from?
All FDA import refusal data for Ilo Electronic 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.