FDA Registration
Active
🇩🇪 Germany
Impella CP
Reg #: 3007904765
·
FEI: 3007904765
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABIOMED EUROPE GMBH
- Registration Number
- 3007904765
- FEI Number
- 3007904765
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Neuenhofer Weg 3
- City
- Aachen North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- PMA Number
- P140003
Owner / Operator
- Firm Name
- Abiomed Europe GmbH
- Operator Number
- 10030761
- Address
- Neuenhofer Weg 3
- City
- Aachen
- State
- North Rhine-Westphalia
- Postal Code
- 52074
- Country
- DE
US Agent
- Business Name
- Abiomed, Inc.
- Contact Name
- Anshul Shah
- Address
- 22 Cherry Hill Drive
- City
- Danvers
- State
- MA
- ZIP
- 01923
- Country
- US
- [email protected]
- Phone
- 323 5415318
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Temporary Non-Roller Type Left Heart Support Blood Pump | OZD | Class 3 | Unknown | No | 2018-02-27 |
Proprietary Names
Impella CP
Impella LD
Impella 5
Impella 2.5
Establishment Types
Manufacture Medical Device