Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003828812

FEI Number

3003828812

Entity Name

HANS BIOMED CORP.

City/State/Country

Daejeon, KR

Establishment Address

64, YUSEONG-DAERO 1628 BEON-GIL, Yuseong-gu, Daejeon 34054, KR

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HANS BIOMED CORP. (Owner Number: 9054234)

Owner / Operator Contact Address

64, Yuseong-daero 1628 beon-gil, Yuseong-gu, Daejeon, KR-NOTA 34054, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K113728

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2023-03-30
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2023-03-30
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-12-03
NUN	Bone Grafting Material, Human Source	Dental	Class 2	872.3930	2014-02-20
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-02-20
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2006-04-26
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2020-11-30
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2013-08-16
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2016-04-07
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2016-04-07
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2013-01-12
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-12

Official Correspondent

Mark Bae

US Agent Details

Kevin Chun Business: Hans Biomed USA Inc. Email: qra@hansbiomed.us Phone: (562) 6156813

Related Public Records

Same Entity

HANS BIOMED CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0014-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003828812. Last updated year: 2026. Please use registration number 3003828812 when referencing this establishment in official correspondence.