Data / Medical devices / South Korea / Hans Biomed Corp.
Hans Biomed Corp.: FDA-registered device maker in Daejeon, South Korea, 9 510(k) clearances
Hans Biomed Corp. is registered with the FDA (registration 3003828812) in Daejeon, South Korea. It lists 10 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 18, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003828812
- Address
- 64, YUSEONG-DAERO 1628 BEON-GIL Yuseong-gu, Daejeon, South Korea, 34054
- Owner or operator
- HANS BIOMED CORP. (9054234)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- April 26, 2006
- Registered through
- 2026
- Brand names listed
- BellaFuse, CICA-DAMIA GEL PLUS, CICA-DAMIA SHEET, Cellromax Skina Gel, Derma SC-GEL, Double Blunt Needle, ExFuse, ExFuse(tm) II Putty and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Human Source | NUN | 2 | Manufacturer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | 2 | Manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Needle, Suturing, Reusable | GDL | 1 | Manufacturer | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 18, 2026 | K254238 | MINT MONO Sutures | NEW | Substantially Equivalent | Hans Biomed Corporation | accessdata.fda.gov |
| March 7, 2023 | 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 | Substantially Equivalent | Hans Biomed Corporation | accessdata.fda.gov |
| September 9, 2020 | K192423 | MINT Product Family | NEW | Substantially Equivalent | Hans Biomed Corporation | accessdata.fda.gov |
| February 22, 2018 | K171568 | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty | MQV | Substantially Equivalent | Hans Biomed Corporation | accessdata.fda.gov |
| April 21, 2016 | K152077 | MaxiGen | MQV | Substantially Equivalent | Hans Biomed Corp. | accessdata.fda.gov |
| March 11, 2016 | K151271 | BellaFuse | MQV | Substantially Equivalent | Hans Biomed Corp. | accessdata.fda.gov |
| January 10, 2014 | K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | NUN | Substantially Equivalent | Hans Biomed Corp. | accessdata.fda.gov |
| June 12, 2013 | K130191 | MINT | NEW | Substantially Equivalent | Hans Biomed Corporation | accessdata.fda.gov |
| November 15, 2012 | K113728 | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY | MBP | Substantially Equivalent | Hans Biomed Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Guide, Needle, Surgical
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
- All makers of Suture, Surgical, Absorbable, Polydioxanone
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.