Data / Medical devices / El Salvador / Laboratorios Biogalenic, S.A. de C.V.
Laboratorios Biogalenic, S.A. de C.V.: FDA-registered device maker in Soyapango San Salvador, El Salvador, 4 510(k) clearances
Laboratorios Biogalenic, S.A. de C.V. is registered with the FDA (registration 3006785496) in Soyapango San Salvador, El Salvador. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 14, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006785496
- Address
- Calle Claper Blvd. Del Ejercito Nacional km 5.5, Soyapango San Salvador, El Salvador, 1639 SV
- Owner or operator
- Laboratorios Biogalenic Sociedad Anonima de Capital Variable (10084089)
- Roles
- Manufacturer
- First device listed
- January 19, 2022
- Registered through
- 2026
- Brand names listed
- Sterile Water for Inhalation
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 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 14, 2026 | K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | BTT | Substantially Equivalent | Laboratorios Biogalenic S.A. DE C.V. | accessdata.fda.gov |
| March 6, 2025 | K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USP | FRO | Substantially Equivalent | Laboratorios Biogalenic S.A. DE C.V. | accessdata.fda.gov |
| January 30, 2025 | K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | BTT | Substantially Equivalent | Laboratorios Biogalenic S.A. DE C.V. | accessdata.fda.gov |
| May 25, 1988 | K881184 | INTERTECH STERILE WATER FOR INHALATION | BTT | Substantially Equivalent | Delmed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Dressing, Wound, Drug
Updated January 14, 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.