Data / Medical devices / South Korea / T&R Biofab Co.,ltd.
T&R Biofab Co.,ltd.: FDA-registered device maker in Siheung-si Gyeonggi, South Korea, 2 510(k) clearances
T&R Biofab Co.,ltd. is registered with the FDA (registration 3016901080) in Siheung-si Gyeonggi, South Korea. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 30, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016901080
- Address
- 96, Mayu-ro, Siheung-si Gyeonggi, South Korea, 15111
- Owner or operator
- T&R BIOFAB CO.,LTD. (10082367)
- Roles
- Manufacturer
- First device listed
- May 10, 2022
- Registered through
- 2026
- Brand names listed
- Bonofoam, Bonofoam A Band, Bonofoam Band, Bonofoam Band Plus, Bonofoam S Band, Elastonz-gel S, Reproderm-gel, Reproderm-gel S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid, Skin Protectant | NEC | 1 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Manufacturer | accessdata.fda.gov |
| Methyl Methacrylate For Cranioplasty | GXP | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | 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 |
|---|---|---|---|---|---|---|
| July 30, 2026 | K251959 | TnR Cranial Implant | GXP | Substantially Equivalent | T&R BIOFAB CO., Ltd. | accessdata.fda.gov |
| December 5, 2023 | K222057 | THERMOCLICK | FLL | Substantially Equivalent | T&R BIOFAB CO., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Tape And Bandage, Adhesive
- All makers of Dressing, Wound, Hydrophilic
- All makers of Dressing, Wound, Occlusive
- All makers of Methyl Methacrylate For Cranioplasty
- All makers of Bandage, Liquid, Skin Protectant
Updated July 30, 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.