FDA Registration
Active
🇲🇽 Mexico
Border Assembly S de RL de CV
Reg #: 3023851856
·
FEI: 3023851856
·
Expires 2026
Products
6
Proprietary Names
2
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- Border Assembly S de RL de CV
- Registration Number
- 3023851856
- FEI Number
- 3023851856
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- AVENIDA PASEO DE LA REFORMA, 8950-E1 COLONIA RUBIO
- City
- TIJUANA Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K230718
Owner / Operator
- Firm Name
- Gilero, Inc
- Operator Number
- 10053703
- Address
- 4319 S. Alston Ave., Suite 100
- City
- Durham
- State
- NC
- Postal Code
- 27713
- Country
- US
US Agent
- Business Name
- Gilero, LLC
- Contact Name
- Andrew Williams
- Address
- 4319 S Alston Ave Ste 100
- City
- Durham
- State
- NC
- ZIP
- 27713
- Country
- US
- [email protected]
- Phone
- 919 5330009
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-02-21 |
| Intravenous Catheter Force-Activated Separation Device. | QOI | Class 2 | General Hospital | No | 2023-12-07 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2024-02-21 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2024-10-10 |
| Accessories, Pump, Infusion | MRZ | Class 2 | General Hospital | No | 2023-06-28 |
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2021-05-12 |
Proprietary Names
12cc Syringe Kit
6cc Syringe Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198