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Gentuity HF-OCT Imaging System - Coronary optical coherence tomography system - TGA Drug Approval Details
Approvals
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TGA
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Gentuity HF-OCT Imaging System - Coronary optical coherence tomography system
Approved
STANDARD
Gentuity HF-OCT Imaging System - Coronary optical coherence tomography system
Nipro Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Jul 23, 2025
Approval ID
706127c02f00b040
Company
Nipro Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
706127c02f00b040
Product Name
Gentuity HF-OCT Imaging System - Coronary optical coherence tomography system
Artg Id
503706
Artg Name
Nipro Australia Pty Ltd - Gentuity HF-OCT Imaging System - Coronary optical coherence tomography system
Sponsor
Nipro Australia Pty Ltd
Artg Date
2025-07-21
Registration Type
Device
Therapeutic Good Type
Medical device
Licence Status
A
Licence Category
INC
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Jul 23, 2025
Approval ID
706127c02f00b040
Type
Standard
Back to TGA Approvals
