MaxiGen
HANS BIOMED CORP.
HANS BIOMED CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003828812 | 3003828812 | HANS BIOMED CORP. | 1 | N | 2027-01-01 | 64, YUSEONG-DAERO 1628 BEON-GIL Yuseong-gu Daejeon KR 34054 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 21355 | 1012805929 | K254238 | MINT MONO Sutures | NEW | 2026-09-18 |
| 21355 | 1116591211 | K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 | NEW | 2023-03-07 |
| 21355 | 1131915898 | K192423 | MINT Product Family | NEW | 2020-09-09 |
| 21355 | 1967173301 | K171568 | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty | MQV | 2018-02-22 |
| 21355 | 1853562205 | K152077 | MaxiGen | MQV | 2016-04-21 |
| 21355 | 1068266747 | K151271 | BellaFuse | MQV | 2016-03-11 |
| 21355 | 1668548661 | K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | NUN | 2014-01-10 |
| 21355 | 1351311161 | K130191 | MINT | NEW | 2013-06-12 |
| 21355 | 2004632594 | K113728 | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY | MBP | 2012-11-15 |
| 21355 | 1502161032 | ||||
| 21355 | 1523368318 | ||||
| 21355 | 1534373447 | ||||
| 21355 | 1652710764 | ||||
| 21355 | 1816888133 |
Product Codes Associated With Registrations#
PMN#
BellaFuse
Hans Biomed Corp.
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
HANS BIOMED CORP.
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
HANS BIOMED CORP.
GUDID#
MINT MONO Sutures - MINT Product Family Sutures, including MINT MONO Sutures, are synthetic, absorbable, sterile, surgical sutures comprised of polydioxanone. They are available in a range of lengths and thicknesses. They are provided sterile. They degrade and resorb over time. MINT MONO Sutures are smooth sutures. MINT MONO Sutures are part of the MINT Product Family of Sutures.
2026-10-20
MINT MONO Sutures - MINT Product Family Sutures, including MINT MONO Sutures, are synthetic, absorbable, sterile, surgical sutures comprised of polydioxanone. They are available in a range of lengths and thicknesses. They are provided sterile. They degrade and resorb over time. MINT MONO Sutures are smooth sutures. MINT MONO Sutures are part of the MINT Product Family of Sutures.
2026-10-20
MINT MONO Sutures - MINT Product Family Sutures, including MINT MONO Sutures, are synthetic, absorbable, sterile, surgical sutures comprised of polydioxanone. They are available in a range of lengths and thicknesses. They are provided sterile. They degrade and resorb over time. MINT MONO Sutures are smooth sutures. MINT MONO Sutures are part of the MINT Product Family of Sutures.
2026-10-20
MINT MONO Sutures - MINT Product Family Sutures, including MINT MONO Sutures, are synthetic, absorbable, sterile, surgical sutures comprised of polydioxanone. They are available in a range of lengths and thicknesses. They are provided sterile. They degrade and resorb over time. MINT MONO Sutures are smooth sutures. MINT MONO Sutures are part of the MINT Product Family of Sutures.
2026-10-20
MINT MONO Sutures - MINT Product Family Sutures, including MINT MONO Sutures, are synthetic, absorbable, sterile, surgical sutures comprised of polydioxanone. They are available in a range of lengths and thicknesses. They are provided sterile. They degrade and resorb over time. MINT MONO Sutures are smooth sutures. MINT MONO Sutures are part of the MINT Product Family of Sutures.
2026-10-20
MINT MONO Sutures - MINT Product Family Sutures, including MINT MONO Sutures, are synthetic, absorbable, sterile, surgical sutures comprised of polydioxanone. They are available in a range of lengths and thicknesses. They are provided sterile. They degrade and resorb over time. MINT MONO Sutures are smooth sutures. MINT MONO Sutures are part of the MINT Product Family of Sutures.
2026-10-20
Exponent - EXP00
2017-03-09
TruForm+ - 0.3cc(DEMONSTRATION)
2017-07-18
TruForm+ - 0.5cc(DEMONSTRATION)
2017-07-18
TruForm+ - 1.0cc(DEMONSTRATION)
2017-07-18
TruForm+ - 3.0cc(DEMONSTRATION)
2017-07-18
TruForm+ - 5.0cc(DEMONSTRATION)
2017-07-18
TruForm+ - 10.0cc(DEMONSTRATION)
2017-07-18
TruForm+ - 1.0cc(DEMONSTRATION)
2017-07-18
TruForm+ - 3.0cc(DEMONSTRATION)
2017-07-18
TruForm+ - 5.0cc(DEMONSTRATION)
2017-07-18
TruForm+ - 10.0cc(DEMONSTRATION)
2017-07-18
TruForm - 0.3cc(DEMONSTRATION)
2017-07-18
TruForm - 0.5cc(DEMONSTRATION)
2017-07-18
TruForm - 1.0cc(DEMONSTRATION)
2017-07-18
TruForm - 3.0cc(DEMONSTRATION)
2017-07-18
TruForm - 5.0cc(DEMONSTRATION)
2017-07-18
TruForm - 10.0cc(DEMONSTRATION)
2017-07-18
TruForm - 1.0cc(DEMONSTRATION)
2017-07-18
TruForm - 3.0cc(DEMONSTRATION)
2017-07-18
TruForm - 5.0cc(DEMONSTRATION)
2017-07-18
TruForm - 10.0cc(DEMONSTRATION)
2017-07-18
Exponent - EXP01
2015-09-24
Exponent - EXP03
2015-09-24
Exponent - EXP05
2015-09-24
Exponent - EXP10
2015-09-24
Vivex DBM Plus - VX-EP1
2015-09-24
Vivex DBM Plus - VX-EP3
2015-09-24
Vivex DBM Plus - VX-EP5
2015-09-24
Vivex DBM Plus - VX-EP10
2015-09-24
CureMix Plus - 2016-0001
2015-09-24
CureMix Plus - 2016-0003
2015-09-24
CureMix Plus - 2016-0005
2015-09-24
CureMix Plus - 2016-0010
2015-09-24
OsteoPore Gen-II DBM - SC4105DBM
2015-09-24