Shimadzu Medical Systems
✅ Low Risk
FEI: 1000125362 • Long Beach, CA • UNITED STATES
FEI Number
1000125362
Location
Long Beach, CA
Country
UNITED STATESAddress
3645 N Lakewood Blvd, , Long Beach, CA, United States
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 |
|---|---|---|---|
| 6/24/2005 | 78KYHENDOSCOPE, OPHTHALMIC | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Shimadzu Medical Systems's FDA import refusal history?
Shimadzu Medical Systems (FEI: 1000125362) has 1 FDA import refusal record(s) in our database, spanning from 6/24/2005 to 6/24/2005.
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. Shimadzu Medical Systems's FEI number is 1000125362.
What types of violations has Shimadzu Medical Systems received?
Shimadzu Medical Systems 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 Shimadzu Medical Systems come from?
All FDA import refusal data for Shimadzu Medical Systems 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.