Summary for ARTG Entry:
Nipro Australia Pty Ltd - Hollow-fibre haemodialysis dialyser, high flux, single-use
ARTG entry for
Medical Device Included Class IIb
Nipro Australia Pty Ltd
Level 2 / 657 Pacific Highway St Leonards,Sydney, NSW, 2065
ARTG Start Date
Medical Device Class IIb
- 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.
Nipro India Corporation Pvt Ltd
Plt No E-1 MIDC Kesurdi Taluka-Khandala
District-Satara, Maharashtra, 412802
1. Hollow-fibre haemodialysis dialyser, high flux, single-use
Single Device Product
47072 Hollow-fibre haemodialysis dialyser, high flux, single-use
Intended for use to perform Haemodialysis treatments for patients having acute or chronic renal failure.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:04:43 AEDT
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