Data / Medical devices / Mexico / Border Assembly S de RL de CV
Border Assembly S de RL de CV: FDA-registered device maker in TIJUANA Baja California, Mexico, 2 510(k) clearances
Border Assembly S de RL de CV is registered with the FDA (registration 3023851856) in TIJUANA Baja California, Mexico. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023851856
- Address
- Avenida Paseo De La Reforma 8950-E1 Colonia Rubio, TIJUANA Baja California, Mexico, 22116
- Owner or operator
- Gilero, Inc (10053703)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- May 12, 2021
- Registered through
- 2026
- Brand names listed
- 12cc Syringe Kit, 6cc Syringe Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Contract manufacturer | accessdata.fda.gov |
| Injector, Contrast Medium, Automatic | IZQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Intravenous Catheter Force-Activated Separation Device. | QOI | 2 | Contract manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| June 15, 2023 | K230718 | UTC 3mL Medication Cartridge | MRZ | Substantially Equivalent | Gilero, LLC | accessdata.fda.gov |
| May 6, 2021 | K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | KPE | Substantially Equivalent | Gilero, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Set, I.V. Fluid Transfer
- All makers of Container, I.V.
- All makers of Intravenous Catheter Force-Activated Separation Device.
- All makers of Syringe, Piston
- All makers of Accessories, Pump, Infusion
- All makers of Injector, Contrast Medium, Automatic
Updated June 15, 2023. 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.