FDA Registration
Active
🇮🇱 Israel
Flextronics (Israel) LTD
Reg #: 3009243923
·
FEI: 3009243923
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Flextronics (Israel) LTD
- Registration Number
- 3009243923
- FEI Number
- 3009243923
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 Hamatechet Street
- City
- Migdal Haemek Northern
- Country
- IL
Owner / Operator
- Firm Name
- Flextronics International USA, Inc.
- Operator Number
- 9006592
- Address
- 12455 Research Blvd
- City
- Austin
- State
- TX
- Postal Code
- 78759
- Country
- US
- Correspondent
- Chad Ashton
US Agent
- Business Name
- FLEXTRONICS INTERNATIONAL USA, INC.
- Contact Name
- Chad Ashton
- Address
- 12455 Research Blvd
- City
- Austin
- State
- TX
- ZIP
- 78759
- Country
- US
- [email protected]
- Phone
- 901 8712423
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2022-04-27 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2019-04-03 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2022-04-27 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2023-01-11 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2025-11-26 |
Proprietary Names
CELSIUS
: CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH, THERMOCOOL SMARTTO
NAVISTAR
QDOT Micro Catheter with nGEN Generator
nGEN Pump
TRUPULSE Generator
Dual Sensor (DS) Catheters
NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)