SELVAS Healthcare, Inc.
⚠️ Moderate Risk
FEI: 3001058906 • Yuseong, DAEJEON • SOUTH KOREA
FEI Number
3001058906
Location
Yuseong, DAEJEON
Country
SOUTH KOREAAddress
155 Sinseong-Ro, , Yuseong, DAEJEON, South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 SELVAS Healthcare, Inc.'s FDA import refusal history?
SELVAS Healthcare, Inc. (FEI: 3001058906) has 2 FDA import refusal record(s) in our database, spanning from 5/7/2025 to 5/7/2025.
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. SELVAS Healthcare, Inc.'s FEI number is 3001058906.
What types of violations has SELVAS Healthcare, Inc. received?
SELVAS Healthcare, Inc. 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 SELVAS Healthcare, Inc. come from?
All FDA import refusal data for SELVAS Healthcare, Inc. 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.