FDA Registration
Active
🇩🇪 Germany
COMPOGUARD
Reg #: 3004634229
·
FEI: 3004634229
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- FRESENIUS HEMOCARE GMBH
- Registration Number
- 3004634229
- FEI Number
- 3004634229
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gruener Weg 10
- City
- Friedberg Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- BK040005
Owner / Operator
- Firm Name
- Fresenius Kabi AG
- Operator Number
- 9027285
- Address
- Else-Kroner-Str. 1
- City
- 61352 Bad Homburg
- State
- DE-NOTA
- Postal Code
- NONE
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Blood Mixing And Blood Weighing | KSQ | Class 1 | Hematology | No | 2007-11-16 |
Proprietary Names
COMPOGUARD
HEMOLIGHT PLUS
DONATION MASTER NT
COMPOGUARD ADVANCE
DONATIONMASTER ADVANCE SOFTWARE
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device