FDA Registration
Active
🇨🇭 Switzerland
CentriMag Pre-connected Pack
Reg #: 3010163695
·
FEI: 3010163695
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- APPLIMED SA -CSSR
- Registration Number
- 3010163695
- FEI Number
- 3010163695
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Route de Pra de Plan 3
- City
- Châtel St Denis Fribourg
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K222297
Owner / Operator
- Firm Name
- Applimed SA
- Operator Number
- 10042371
- Address
- Route de Pra de Plan 1
- City
- Châtel St Denis
- State
- Fribourg
- Postal Code
- 1618
- Country
- CH
- Correspondent
- Sasan Danechi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | Class 2 | Cardiovascular | No | 2024-01-23 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2024-01-23 |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2024-01-23 |
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2024-01-23 |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | Class 2 | Cardiovascular | No | 2024-01-23 |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | Class 2 | Cardiovascular | No | 2024-01-23 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2024-01-23 |
Proprietary Names
CentriMag Pre-connected Pack
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)