Ge Medical Systems Korea
✅ Low Risk
FEI: 3007888338 • Seoul, Seoul Teugbyeolsi • SOUTH KOREA
FEI Number
3007888338
Location
Seoul, Seoul Teugbyeolsi
Country
SOUTH KOREAAddress
Yoksam 2 Dong, , Seoul, Seoul Teugbyeolsi, South Korea
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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
Frequently Asked Questions
What is Ge Medical Systems Korea's FDA import refusal history?
Ge Medical Systems Korea (FEI: 3007888338) has 1 FDA import refusal record(s) in our database, spanning from 10/4/2021 to 10/4/2021.
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 Medical Systems Korea's FEI number is 3007888338.
What types of violations has Ge Medical Systems Korea received?
Ge Medical Systems Korea 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 Ge Medical Systems Korea come from?
All FDA import refusal data for Ge Medical Systems Korea 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.