FDA Registration
Active
🇵🇦 Panama
PREMIUM BRANDS GROUP, S.A
Reg #: 3009429841
·
FEI: 3009429841
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- PREMIUM BRANDS GROUP, S.A
- Registration Number
- 3009429841
- FEI Number
- 3009429841
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Calle 6ta. Avenida 5ta. Zona Libre de Colon, Panama
- City
- Colon, Panama
- Country
- PA
Regulatory Submissions
- 510(k) Number
- K112478
Owner / Operator
- Firm Name
- Premium Brands Group, S.A
- Operator Number
- 10055796
- Address
- Calle 6ta. Avenida 5ta. Zona Libre de Colon, Panama
- City
- Colon, Panama
- State
- PA-3
- Postal Code
- 0301-174
- Country
- PA
- Correspondent
- Mark Guttman
US Agent
- Business Name
- SSPT Inc
- Contact Name
- Celia Parnicky
- Address
- 100 Se 3rd Ave Fl 10 Ste 1000
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33394
- Country
- US
- [email protected]
- Phone
- 954 2610657
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2019-11-20 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-11-20 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2019-11-20 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-11-20 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2019-11-20 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device