FDA Registration
Active
🇩🇪 Germany
QUADROX-iD Diffusion Membrane Oxygenators with Holding Clamp.
Reg #: 8010762
·
FEI: 3009649876
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- MAQUET CARDIOPULMONARY GmbH
- Registration Number
- 8010762
- FEI Number
- 3009649876
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Neue Rottenburger Strasse 37
- City
- Hechingen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K132829
Owner / Operator
- Firm Name
- Maquet Cardiopulmonary GmbH
- Operator Number
- 8010762
- Address
- Kehler Strasse 31
- City
- Rastatt
- State
- Baden-Wurttemberg
- Postal Code
- 76437
- Country
- DE
- Correspondent
- Tom Peters
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2014-01-15 |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2014-01-15 |
| Filter, Blood, Cardiopulmonary Bypass, Arterial Line | DTM | Class 2 | Cardiovascular | No | 2014-01-15 |
Proprietary Names
QUADROX-iD Diffusion Membrane Oxygenators with Holding Clamp.
Establishment Types
Manufacture Medical Device