Data / Medical devices / Brazil / Phelcom Technologies
Phelcom Technologies: FDA-registered device maker in Sao Carlos Sao Paulo, Brazil, 2 510(k) clearances
Phelcom Technologies is registered with the FDA (registration 3017175640) in Sao Carlos Sao Paulo, Brazil. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017175640
- Address
- Rua Jose Missali, 820 Santa Felicia, Sao Carlos Sao Paulo, Brazil, 13562-405
- Owner or operator
- Phelcom Technologies (10072211)
- Roles
- Manufacturer
- First device listed
- July 15, 2020
- Registered through
- 2027
- Brand names listed
- EYER RETINAL CAMERA NM-STD, Eyer 2, Eyer 2 Basic, Eyer 2 Essential, Eyer Retinal Camera - M-STD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Manufacturer | accessdata.fda.gov |
| Camera, Ophthalmic, General-Use | PJZ | 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 |
|---|---|---|---|---|---|---|
| January 16, 2026 | K251353 | Eyer 2 | HKI | Substantially Equivalent | Phelcom Technologies | accessdata.fda.gov |
| February 22, 2023 | K221329 | Eyer Retinal Camera NM-STD | HKI | Substantially Equivalent | Phelcom Technologies | accessdata.fda.gov |
Compare with other makers
Updated January 16, 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.