FDA Registration
Active
🇺🇸 United States
Teleflex Medical OEM LLC
Reg #: 3005232773
·
FEI: 3005232773
·
Expires 2026
Products
8
Proprietary Names
5
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Teleflex Medical OEM LLC
- Registration Number
- 3005232773
- FEI Number
- 3005232773
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3750 Annapolis Ln N Ste 160
- City
- Plymouth
- State
- MN
- ZIP
- 55447
- Country
- US
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2023-11-30 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2023-11-30 |
| Accessories, Catheter, G-U | KNY | Class 2 | Gastroenterology, Urology | No | 2013-07-02 |
| Snare, Surgical | GAE | Class 1 | General, Plastic Surgery | No | 2016-11-28 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2016-11-28 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2016-11-28 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2016-11-28 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2013-01-08 |
Proprietary Names
Endophys Pressure Sensing Sheath Kit
Uro Pass Ureteral Access Sheath
Endophys Pressure Sensing Sheath
Endophys Pressure Sensing Sheath Kit-8F
Uro-Pass
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)