Hans Biomed Corp
⚠️ Moderate Risk
FEI: 3011437141 • Seoul Si Sung • SOUTH KOREA
FEI Number
3011437141
Location
Seoul Si Sung
Country
SOUTH KOREAAddress
Rm807 Sk Bldg, , Seoul Si Sung, , 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).
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).
3905
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 |
|---|---|---|---|
| 8/5/2025 | 87MBPFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) | Division of West Coast Imports (DWCI) | |
| 4/22/2016 | 87MQVFILLER, CALCIUM SULFATE PREFORMED PELLETS | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 4/22/2016 | 76NUNBONE GRAFTING MATERIAL, HUMAN SOURCE | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Hans Biomed Corp's FDA import refusal history?
Hans Biomed Corp (FEI: 3011437141) has 3 FDA import refusal record(s) in our database, spanning from 4/22/2016 to 8/5/2025.
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. Hans Biomed Corp's FEI number is 3011437141.
What types of violations has Hans Biomed Corp received?
Hans Biomed Corp has been cited for 4 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 Hans Biomed Corp come from?
All FDA import refusal data for Hans Biomed 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.