Data / Medical devices / Japan / 3-D Matrix, Ltd.
3-D Matrix, Ltd.: FDA-registered device maker in Chiyoda-ku Tokyo, Japan, 4 510(k) clearances
3-D Matrix, Ltd. is registered with the FDA (registration 3007162658) in Chiyoda-ku Tokyo, Japan. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 3, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007162658
- Address
- Frontier Kojimachi Building 7F, Kojimachi 3-2-4, Chiyoda-ku Tokyo, Japan, 102-0083
- Owner or operator
- 3-D Matrix, Ltd. (10061211)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- September 17, 2019
- Registered through
- 2026
- Brand names listed
- PuraGel, PuraStat, Syringe Adapter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Connector, Catheter | GCD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Hemostatic Device For Endoscopic Gastrointestinal Use | QAU | 2 | Exporter to the US | accessdata.fda.gov |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | 2 | Exporter to the US | accessdata.fda.gov |
| Protective Coating, Mucoadhesive Application, For The Rectal Mucosa | PHN | U | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| August 3, 2026 | K261504 | PuraStat-RM | PHN | Substantially Equivalent | 3-D Matrix, Inc. | accessdata.fda.gov |
| August 3, 2026 | K261503 | PuraStat GI | QAU | Substantially Equivalent | 3-D Matrix, Inc. | accessdata.fda.gov |
| June 25, 2021 | K210098 | PuraStat-GI | QAU | Substantially Equivalent | 3-D Matrix, Inc. | accessdata.fda.gov |
| April 12, 2019 | K183015 | PuraSinus | NHB | Substantially Equivalent | 3-D Matrix, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer, Ear, Nose And Throat, Synthetic, Absorbable
- All makers of Hemostatic Device For Endoscopic Gastrointestinal Use
- All makers of Connector, Catheter
- All makers of Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Updated August 3, 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.