HANSBIOMED CORP
⚠️ High Risk
FEI: 3016421553 • Seongpa • SOUTH KOREA
FEI Number
3016421553
Location
Seongpa
Country
SOUTH KOREAAddress
11f 7, Jeongul-Ro-8-Gil, Seoul, Seongpa, , South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/23/2025 | 87MBPFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HANSBIOMED CORP's FDA import refusal history?
HANSBIOMED CORP (FEI: 3016421553) has 1 FDA import refusal record(s) in our database, spanning from 9/23/2025 to 9/23/2025.
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. HANSBIOMED CORP's FEI number is 3016421553.
What types of violations has HANSBIOMED CORP received?
HANSBIOMED CORP 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 HANSBIOMED CORP come from?
All FDA import refusal data for HANSBIOMED CORP 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.