Hans Biomed Corporation
⚠️ High Risk
FEI: 3003828812 • Yuseong District, Daejeon • SOUTH KOREA
FEI Number
3003828812
Location
Yuseong District, Daejeon
Country
SOUTH KOREAAddress
64 Yuseong-Daero 1628 Beon-Gil, , Yuseong District, Daejeon, 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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
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.
TISSUE
This human cell, tissue, and cellular and tissue-based product is in violation of Section 361 of the Public Health Service Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2025 | 57JH03BONE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2025 | 57JH03BONE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2025 | 57JH03BONE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2025 | 57JH03BONE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2025 | 57JH03BONE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2025 | 57JH03BONE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2025 | 57JH03BONE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2025 | 57JH03BONE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2025 | 57JH03BONE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 9/3/2025 | 87MQVFILLER, CALCIUM SULFATE PREFORMED PELLETS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/9/2021 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of Southeast Imports (DSEI) | |
| 3/28/2014 | 89MBPFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) | Seattle District Office (SEA-DO) | |
| 3/28/2014 | 89MBPFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) | Seattle District Office (SEA-DO) | |
| 3/28/2014 | 89MBPFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) | Seattle District Office (SEA-DO) | |
| 3/28/2014 | 89MBPFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) | Seattle District Office (SEA-DO) | |
| 3/28/2014 | 89MBPFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) | Seattle District Office (SEA-DO) | |
| 9/16/2004 | 57OY01SKIN (HUMAN TISSUE, OTHER TISSUES) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/29/2003 | 57OH01SKIN (HUMAN TISSUE, OTHER TISSUES) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Hans Biomed Corporation's FDA import refusal history?
Hans Biomed Corporation (FEI: 3003828812) has 18 FDA import refusal record(s) in our database, spanning from 9/29/2003 to 12/17/2025.
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 Corporation's FEI number is 3003828812.
What types of violations has Hans Biomed Corporation received?
Hans Biomed Corporation has been cited for 6 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 Corporation come from?
All FDA import refusal data for Hans Biomed Corporation 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.