GE YOKOGAWA MEDICAL SYSTEMS
✅ Low Risk
FEI: 3013289836 • TOKYO • JAPAN
FEI Number
3013289836
Location
TOKYO
Country
JAPANAddress
TACHIHI BLDG 2 6-1-3- S, , TOKYO, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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 GE YOKOGAWA MEDICAL SYSTEMS's FDA import refusal history?
GE YOKOGAWA MEDICAL SYSTEMS (FEI: 3013289836) has 1 FDA import refusal record(s) in our database, spanning from 4/3/2017 to 4/3/2017.
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. GE YOKOGAWA MEDICAL SYSTEMS's FEI number is 3013289836.
What types of violations has GE YOKOGAWA MEDICAL SYSTEMS received?
GE YOKOGAWA MEDICAL SYSTEMS has been cited for 3 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 GE YOKOGAWA MEDICAL SYSTEMS come from?
All FDA import refusal data for GE YOKOGAWA 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.