Summary for ARTG Entry:
Cardioscan Services Pty Ltd - Electrocardiograph, Holter analyser, software
ARTG entry for
Medical Device Included Class IIa
Cardioscan Services Pty Ltd
Suite 301 12 Cato Street,HAWTHORN EAST, VIC, 3123
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.
Biomedical Instruments Co Ltd
Room 805 Western Section Huatai Building
Futain District, Shenzhen, 518034
1. Electrocardiograph, Holter analyser, software
Single Device Product
41651 Electrocardiograph, Holter analyser, software
The analysis software is intended to scan, analyse ambulatory ECG data and generate an analytical
report, which serves as a reference for clinical diagnosis by physicians.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:26:01 AEDT
This is not an ARTG Certificate document.
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