Data / Medical devices / Japan / Tamabio Co.,ltd.
Tamabio Co.,ltd.: FDA-registered device maker in Musashino-shi Tokyo, Japan, 1 510(k) clearance
Tamabio Co.,ltd. is registered with the FDA (registration 3041851334) in Musashino-shi Tokyo, Japan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3041851334
- Address
- 402 2-2-18 Sakai, Musashino-shi Tokyo, Japan, 180-0022
- Owner or operator
- TamaBio Co.,Ltd. (10094178)
- Roles
- Manufacturer
- First device listed
- November 18, 2025
- Registered through
- 2026
- Brand names listed
- PeriBeam
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 2 | 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 |
|---|---|---|---|---|---|---|
| April 18, 2025 | K240775 | PeriBeam® Pericardial Membrane | DXZ | Substantially Equivalent | Tamabio | accessdata.fda.gov |
Compare with other makers
Updated April 18, 2025. 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.