Authorized Representative
🇩🇪 Germany
Active
Fresenius Medical Care Deutschland GmbH
SRN: DE-AR-000009269
·
Else-Kröner-Straße 1, 61352 Bad Homburg, Germany
Manufacturers
4
Devices
47
Certificates
3
PRRCs
1
Basic Information
- Address
- Else-Kröner-Straße 1, 61352 Bad Homburg, Germany
- [email protected]
- Phone
- +49 6172 609 0
- Website
- www.freseniusmedicalcare.com
- VAT Number
- DE 812033564
- Trade Register
- HRB 5748
- EORI
- DE3312313
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| FME Seating (Australia) Pty Ltd | 🇦🇺 Australia | AU-MF-000026836 |
| NxStage Medical, Inc. | 🇺🇸 United States | US-MF-000026832 |
| Fresenius Medical Care Production (Australia) Pty Ltd | 🇦🇺 Australia | AU-MF-000036530 |
| Fresenius Medical Care (Jiangsu) Co., Ltd. | 🇨🇳 China | CN-MF-000026839 |
Manufacturers
Fresenius Medical Care (Jiangsu) Co., Ltd.
Manufacturer
🇨🇳 China
FME Seating (Australia) Pty Ltd
Manufacturer
🇦🇺 Australia
NxStage Medical, Inc.
Manufacturer
🇺🇸 United States·47 Basic UDI-DIs·47 Devices·INTERTEK SEMKO AB, INTERTEK SEMKO AB, and INTERTEK SEMKO AB
Fresenius Medical Care Production (Australia) Pty Ltd
Manufacturer
🇦🇺 Australia
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 41314564 | NxStage Medical, Inc. | INTERTEK SEMKO AB | Expired |
| MDD Annex II (excluding section 4) | 41314564 | NxStage Medical, Inc. | INTERTEK SEMKO AB | Expired |
| MDD Annex II (excluding section 4) | 413141564 | NxStage Medical, Inc. | INTERTEK SEMKO AB | Expired |
Devices
NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·11 countries
NXSTAGE CARTRIDGE EXPRESS
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·3 countries
NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·11 countries
PUREFLOW SL PAK
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·12 countries
PUREFLOW SL
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·8 countries
PUREFLOW SL
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·12 countries
PUREFLOW SL
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·8 countries
VersiHD
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·8 countries
EXPRESS FLUID WARMER DISPOSABLE
Device
EU MDD
·
Eu Md Class 2a
·NxStage Medical, Inc.·On the market·13 countries
EXPRESS FLUID WARMER DISPOSABLE
Device
EU MDD
·
Eu Md Class 2a
·NxStage Medical, Inc.·On the market·13 countries
EXPRESS FLUID WARMER DISPOSABLE
Device
EU MDD
·
Eu Md Class 2a
·NxStage Medical, Inc.·On the market·13 countries
EXPRESS FLUID WARMER DISPOSABLE
Device
EU MDD
·
Eu Md Class 2a
·NxStage Medical, Inc.·On the market·13 countries
COMFORTMATE FLUID WARMER DISPOSABLE
Device
EU MDD
·
Eu Md Class 2a
·NxStage Medical, Inc.·On the market·5 countries
COMFORTMATE FLUID WARMER DISPOSABLE
Device
EU MDD
·
Eu Md Class 2a
·NxStage Medical, Inc.·On the market·5 countries
NxStage Express Fluid Warmer
Device
EU MDD
·
Eu Md Class 2a
·NxStage Medical, Inc.·On the market·8 countries
NXSTAGE CARTRIDGE EXPRESS
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·13 countries
NXSTAGE CARTRIDGE
Device
EU MDD
·
Eu Md Class 2a
·NxStage Medical, Inc.·On the market·11 countries
NXSTAGE CARTRIDGE
Device
EU MDD
·
Eu Md Class 2a
·NxStage Medical, Inc.·On the market·13 countries
NXSTAGE PUREFLOW SL DIALYSATE SACK (SAK) CONCENTRATE
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·2 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·2 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·2 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·2 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·2 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·2 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·2 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·6 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·6 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·6 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·6 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·6 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·6 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·6 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries
Dialysate Sack (SAK) with Concentrate
Device
EU MDD
·
Eu Md Class 2b
·NxStage Medical, Inc.·On the market·7 countries