Data / Medical devices / Brazil / DMC Importacao E Exportacao De Equipamentos Ltda
DMC Importacao E Exportacao De Equipamentos Ltda: FDA-registered device maker in Sao Carlos Sao Paulo, Brazil, 2 510(k) clearances
DMC Importacao E Exportacao De Equipamentos Ltda is registered with the FDA (registration 3035375032) in Sao Carlos Sao Paulo, Brazil. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 12, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3035375032
- Address
- Rua Sebastiao de Moraes 831 - Jd Santa Felicia, Sao Carlos Sao Paulo, Brazil, 13562-030
- Owner or operator
- DMC Importacao e Exportacao de Equipamentos Ltda (10092439)
- Roles
- Manufacturer
- First device listed
- January 8, 2025
- Registered through
- 2027
- Brand names listed
- OstomyGel, Therapy EC, Therapy US, Therapy XT, e-light B-US, e-light I-US, e-light V-US
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Stomal | GDS | 1 | Manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | NHN | 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 |
|---|---|---|---|---|---|---|
| December 12, 2025 | K252273 | Therapy US | NHN | Substantially Equivalent | Dmc Importação E Exportação DE Equipamentos Ltda | accessdata.fda.gov |
| December 19, 2024 | K232813 | Therapy EC, Therapy XT | NHN | Substantially Equivalent | Dmc Importacao E Exportacao DE Equipamentos Ltda | accessdata.fda.gov |
Compare with other makers
- All makers of Bag, Stomal
- All makers of Heat Source For Bleaching Teeth
- All makers of Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- All makers of Lamp, Infrared, Therapeutic Heating
Updated December 12, 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.