FDA Registration
Active
🇩🇪 Germany
5008X Hemodialysis System
Reg #: 9611824
·
FEI: 3002806960
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
- Registration Number
- 9611824
- FEI Number
- 3002806960
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HAFENSTRASSE 9
- City
- SCHWEINFURT
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K243505
Owner / Operator
- Firm Name
- FRESENIUS MEDICAL CARE
- Operator Number
- 8010838
- Address
- ELSE KROENER-STRASSE 1, --
- City
- BAD HOMBURG
- State
- Hesse
- Postal Code
- D-61352
- Country
- DE
US Agent
- Business Name
- VP Regulatory Affairs NA
- Contact Name
- Denise Oppermann
- Address
- 920 Winter St
- City
- North Waltham
- State
- MA
- ZIP
- 02451
- Country
- US
- [email protected]
- Phone
- 781 6994479 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2025-06-10 |
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2025-06-10 |
| Accessories, Blood Circuit, Hemodialysis | KOC | Class 2 | Gastroenterology, Urology | No | 2025-06-10 |
| Disinfectant, Dialysate Delivery System | NII | Class 2 | Gastroenterology, Urology | No | 2025-06-10 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2025-06-10 |
Proprietary Names
5008X Hemodialysis System
Establishment Types
Manufacture Medical Device