U2t Photonics Gmbh
⚠️ Moderate Risk
FEI: 3003605319 • Berlin, Berlin • GERMANY
FEI Number
3003605319
Location
Berlin, Berlin
Country
GERMANYAddress
Reuchlinstr. 10/11, , Berlin, Berlin, 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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/24/2006 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is U2t Photonics Gmbh's FDA import refusal history?
U2t Photonics Gmbh (FEI: 3003605319) has 1 FDA import refusal record(s) in our database, spanning from 4/24/2006 to 4/24/2006.
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. U2t Photonics Gmbh's FEI number is 3003605319.
What types of violations has U2t Photonics Gmbh received?
U2t Photonics 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 U2t Photonics Gmbh come from?
All FDA import refusal data for U2t Photonics 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.