Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Fresenius Medical Care Australia Pty Ltd - TPE Bloodline Cassette for Blood purification - Tubing set,
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. TPE Bloodline Cassette for Blood purification - Tubing set, dialysis/haemodialysis
Medical device system
34999 Tubing set, dialysis/haemodialysis
Sterile bloodline tubing system (medical grade soft PVC, with connectors & plastic components) intended
for extracorporeal blood purification as a single-use device (cassette) for connection of a patient's vascular
acccess device to dedicated haemodialysis equipment,ie FMC Multifiltrate or MultifiltratePRO and
associated disposable blood filtration and circulation devices.
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Produced at 02.11.2019 at 05:05:11 AEDT
This is not an ARTG Certificate document.
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