Data / Medical devices / Brazil / Timpel S.A.
Timpel S.A.: FDA-registered device maker in Sao Paulo, Brazil, 3 510(k) clearances
Timpel S.A. is registered with the FDA (registration 3013853674) in Sao Paulo, Brazil. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 10, 2025. 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
- 3013853674
- Address
- R. Simao Alvares, 356 cj. 41 - Pinheiros, Sao Paulo, Brazil, 05417-020
- Owner or operator
- Timpel S.A. (10060388)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 16, 2022
- Registered through
- 2026
- Brand names listed
- Enlight 2100, Enlight 2100 (TPL-E2103-0)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Spirometer, Monitoring (W/Wo Alarm) | BZK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilatory Electrical Impedance Tomograph | QEB | 2 | Manufacturer, Specification developer | 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 10, 2025 | K250464 | Enlight 2100 (TPL-E2103-0) | QEB | Substantially Equivalent | Timpel S.A. | accessdata.fda.gov |
| March 7, 2023 | K222897 | Enlight 2100 | QEB | Substantially Equivalent | Timpel S.A. | accessdata.fda.gov |
| January 6, 2022 | K211135 | Enlight 2100 | QEB | Substantially Equivalent | Timpel S.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilatory Electrical Impedance Tomograph
- All makers of Spirometer, Monitoring (W/Wo Alarm)
Updated September 10, 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.