Diadent Group International
✅ Low Risk
FEI: 3010138769 • Cheongju, Chungcheongbuk • SOUTH KOREA
FEI Number
3010138769
Location
Cheongju, Chungcheongbuk
Country
SOUTH KOREAAddress
Osong-Eup, Heungdeok, Osong-Eub; 16 Osongsaengmyeong4-Ro; Heungdeok, Cheongju, Chungcheongbuk, 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
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 Diadent Group International's FDA import refusal history?
Diadent Group International (FEI: 3010138769) has 2 FDA import refusal record(s) in our database, spanning from 4/20/2005 to 1/10/2006.
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. Diadent Group International's FEI number is 3010138769.
What types of violations has Diadent Group International received?
Diadent Group International 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 Diadent Group International come from?
All FDA import refusal data for Diadent Group International 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.