FDA Registration
Active
🇺🇾 Uruguay
Centro de Construccion de Cardioestimuladores del Uruguay S.A.
Reg #: 3010326622
·
FEI: 3010326622
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- Centro de Construccion de Cardioestimuladores del Uruguay S.A.
- Registration Number
- 3010326622
- FEI Number
- 3010326622
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- General Paz 1363
- City
- Montevideo
- Country
- UY
Owner / Operator
- Firm Name
- GREATBATCH MEDICAL
- Operator Number
- 9035261
- Address
- 2300 Berkshire Lane N, --
- City
- Plymouth
- State
- MN
- Postal Code
- 55441
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb | SAZ | Class 3 | Unknown | No | 2025-02-11 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2023-05-15 |
| Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation | QPY | Class 3 | Unknown | No | 2021-11-01 |
| Implanted Phrenic Nerve Stimulator For Central Sleep Apnea | PSR | Class 3 | Unknown | No | 2017-10-23 |
| Implantable Pulse Generator | QFV | Class 3 | Unknown | No | 2019-05-28 |
| Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief | QLK | Class 3 | Unknown | No | 2021-11-01 |
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | Class 3 | Unknown | No | 2022-11-04 |
Proprietary Names
Presidio MedicalTM Spinal Cord Stimulation (SCS) System
Vivistim System
ReActiv8 System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)