FDA Registration
Active
🇺🇸 United States
ASSURE® Wearable Cardioverter Defibrillator (WCD) system
Reg #: 2031044
·
FEI: 3001236763
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Phillips-Medisize Costa Mesa LLC
- Registration Number
- 2031044
- FEI Number
- 3001236763
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3545 Harbor Blvd Ste 150
- City
- Costa Mesa
- State
- CA
- ZIP
- 92626
- Country
- US
Regulatory Submissions
- PMA Number
- P200037
Owner / Operator
- Firm Name
- Molex, LLC (Phillips Medsize)
- Operator Number
- 10023185
- Address
- 2202 Carmichael Rd
- City
- Hudson
- State
- WI
- Postal Code
- 54016
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wearable Automated External Defibrillator | MVK | Class 3 | Unknown | No | 2021-08-19 |
Proprietary Names
ASSURE® Wearable Cardioverter Defibrillator (WCD) system
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)