Summary for ARTG Entry:
Radiometer Pacific Pty Ltd - Instrument/analyser IVDs
ARTG entry for
Medical Device Included - IVD Class 1
Radiometer Pacific Pty Ltd
PO Box 5134,MOUNT WAVERLEY, VIC, 3149
ARTG Start Date
Medical Device Class 1
- 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.
, Angelholm, 26271
1. Instrument/analyser IVDs
CT943 Instrument/analyser IVDs
HemoCue Analyser's (and accompanying docking stations where relevant), are to be used as an in vitro
diagnostic medical device (IVD) for the purpose of providing information about a clinical specimen.
HemoCue analysers must be used in conjunction with the specified HemoCue microcuvette.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 08:12:40 AEDT
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