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
Phone
562 6156813

Products

Device Name Product Code
Suture, Surgical, Absorbable, Polydioxanone NEW
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
Cannula, Surgical, General & Plastic Surgery GEA
Bone Grafting Material, Human Source NUN
Guide, Needle, Surgical GDF
Elastomer, Silicone, For Scar Management MDA
Filler, Bone Void, Calcium Compound MQV
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
Needle, Suturing, Reusable GDL
Stylet, Surgical, General & Plastic Surgery GAH

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