Omron Creative Marketing Co.,Ltd.Working Model Section
✅ Low Risk
FEI: 3003542851 • Kyoto, Kyoto • JAPAN
FEI Number
3003542851
Location
Kyoto, Kyoto
Country
JAPANAddress
15 Kyotojapan, Umezushirimizo-Cho; Ukyo, Kyoto, Kyoto, Japan
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).
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
Frequently Asked Questions
What is Omron Creative Marketing Co.,Ltd.Working Model Section's FDA import refusal history?
Omron Creative Marketing Co.,Ltd.Working Model Section (FEI: 3003542851) has 1 FDA import refusal record(s) in our database, spanning from 2/6/2002 to 2/6/2002.
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. Omron Creative Marketing Co.,Ltd.Working Model Section's FEI number is 3003542851.
What types of violations has Omron Creative Marketing Co.,Ltd.Working Model Section received?
Omron Creative Marketing Co.,Ltd.Working Model Section 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 Omron Creative Marketing Co.,Ltd.Working Model Section come from?
All FDA import refusal data for Omron Creative Marketing Co.,Ltd.Working Model Section 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.