FDA Registration
Active
🇺🇸 United States
East West Wisconsin
Reg #: 3002736372
·
FEI: 3004631140
·
Expires 2026
Products
10
Proprietary Names
6
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- East West Wisconsin
- Registration Number
- 3002736372
- FEI Number
- 3004631140
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 640 N Prospect Dr
- City
- WHITEWATER
- State
- WI
- ZIP
- 53190
- Country
- US
Owner / Operator
- Firm Name
- East West
- Operator Number
- 10058019
- Address
- 4170 Ashford Dunwoody Rd, suite 560
- City
- Atlanta
- State
- GA
- Postal Code
- 30319
- Country
- US
- Correspondent
- Frank Runner
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2021-12-06 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2021-12-06 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2021-12-06 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2021-12-06 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2021-12-06 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2021-12-06 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-12-06 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-08-31 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2022-08-31 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-08-31 |
Proprietary Names
Cardiochek Bioscanner plus
Apnea Risk Evaluation System ARES-Model 620
3301 PULSE OXIMETER
MedWand Oximeter
Apnea Risk Evaluation System ARES-Model 610
cardiochek Plus Test System, Cardiochek Home Test System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)