Summary for ARTG Entry:
Fresenius Medical Care Australia Pty Ltd - Haemodialysis system dialysate pyrogen filter
ARTG entry for
Medical Device Included Class IIa
Fresenius Medical Care Australia Pty Ltd
Level 17 / 61 Lavender Street,MILSONS POINT, NSW, 2061
ARTG Start Date
Medical Device Class IIa
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Fresenius Medical Care AG & Co KGaA
Else Kroner Strasse 1
Bad Homburg, Bad Homburg, D-61352
1. Haemodialysis system dialysate pyrogen filter
Single Device Product
47739 Haemodialysis system dialysate pyrogen filter
Dialysis Fluid Filters are designed for the ultrafiltration of dialysis fluid. The fluid filter removes pyrogens
from the dialysate, is located "on-line" in the dialysate fluid path and minimises the risk of pyrogen transfer
into the patient's blood.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 09:45:47 AEDT
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