FDA Registration
Active
🇩🇪 Germany
CARDIOHELP-i and multiple accessories
Reg #: 3009507273
·
FEI: 3009507273
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MAQUET CARDIOPULMONARY GmbH
- Registration Number
- 3009507273
- FEI Number
- 3009507273
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kehler Strasse 31
- City
- Rastatt Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K133598
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 |
|---|---|---|---|---|---|
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | Class 2 | Cardiovascular | No | 2014-07-28 |
Proprietary Names
CARDIOHELP-i and multiple accessories
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility