FDA Registration
Active
🇲🇽 Mexico
UroLift System UL400
Reg #: 3003898360
·
FEI: 3003898360
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Teleflex Medical de Tecate, S. de R.L de C.V.
- Registration Number
- 3003898360
- FEI Number
- 3003898360
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- (A Teleflex Medical Company), Prolongacion Mision Eusebio Kino No. 1316,Rancho El Descanso
- City
- TECATE Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K193269
Owner / Operator
- Firm Name
- Teleflex
- Operator Number
- 9062981
- Address
- 3015 Carrington Mill Blvd.
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
- Correspondent
- Divya Raman
US Agent
- Business Name
- Teleflex, Inc.
- Contact Name
- Divya Raman
- Address
- 3015 Carrington Mill Boulevard
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
- [email protected]
- Phone
- 612 4231738
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implantable Transprostatic Tissue Retractor System | PEW | Class 2 | Gastroenterology, Urology | No | 2020-11-24 |
Proprietary Names
UroLift System UL400
Establishment Types
Manufacture Medical Device