FDA Registration
Active
🇰🇷 South Korea
HANS BIOMED CORP.
Reg #: 3003828812
·
FEI: 3003828812
·
Expires 2026
Products
10
Proprietary Names
33
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- HANS BIOMED CORP.
- Registration Number
- 3003828812
- FEI Number
- 3003828812
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 64, YUSEONG-DAERO 1628 BEON-GIL, Yuseong-gu
- City
- Daejeon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K220549
Owner / Operator
- Firm Name
- HANS BIOMED CORP.
- Operator Number
- 9054234
- Address
- 64, Yuseong-daero 1628 beon-gil, Yuseong-gu
- City
- Daejeon
- State
- KR-NOTA
- Postal Code
- 34054
- Country
- KR
- Correspondent
- Mark Bae
US Agent
- Business Name
- Hans Biomed USA Inc.
- Contact Name
- Kevin Chun
- Address
- 10350 Heritage Park Dr Ste 201
- City
- Santa Fe Spgs
- State
- CA
- ZIP
- 90670
- Country
- US
- [email protected]
- Phone
- 562 6156813
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2023-03-30 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2023-03-30 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2015-12-03 |
| Bone Grafting Material, Human Source | NUN | Class 2 | Dental | No | 2014-02-20 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2014-02-20 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2006-04-26 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2016-04-07 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2016-04-07 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2018-09-06 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2011-02-28 |
Proprietary Names
MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures)
MINT Cannula
Mini Cannula
Double Blunt Needle
ExFuse(tm) II Putty
SurFuse(tm) II Putty
Reusable suturing needle
Temporal Needle
Cellromax Skina Gel
SCAR Cln. Stick
ScarClinic(tm)-Gel
Pure Clinic Gel
SCAR CLINIC-THIN
CICA-DAMIA SHEET
NEOSTINE SCAR GEL
SIDMOOL SCAR CARE-GEL
Derma SC-GEL
CICA-DAMIA GEL PLUS
SCAR CLINIC
SCAR Cln. Gel PIH
IZZOr Medi Scar Gel
ScarClinic gel Plus
JadamYou SCARBYE GEL
MINT Product Family
MINT(tm)
BellaFuse
ExFuse
SurFuse
MaxiGen
Ez-Tcon
Lion(tm)
Resorbable calcium salt bone void filler device
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device