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Singapore HSA registration DE0016731

Agfa Healthcare IMPAX Cardiovascular Review Station Software

Singapore flagSingapore·CLASS B·Agfa Healthcare N.V.·Registered January 09, 2015
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration information
Registration Number
DE0016731
Registration Date
January 09, 2015
Retention Due Date
January 08, 2026
Product description
Agfa Healthcare IMPAX Cardiovascular Review Station software enables review, analysis, management, and storage of images in the following modalities: • XA: cardiac X-ray angiography. • US: cardiac ultrasound, including US stress (STR), transesophageal (TEE), transthoracic (TTE), three-dimensional (3D), pediatric (PED) and intravascular (IVUS). • NM: nuclear medicine. • CT: computed tomography • MR: magnetic resonance It also facilitates access to other imaging exams stored in the other PACS system giving the cardiologist one single access point for all the information needed.
Product Owner
Name
Agfa Healthcare N.V.
Short Name
Agfa Healthcare N.V.
Address
Septestraat 27,, 2640 Mortsel, BELGIUM
Registrant
Name
Agfa HealthCare Singapore Pte Ltd
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #08-22, SINGAPORE 408734
Importer
Name
AGFA HEALTHCARE SINGAPORE PTE LTD
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #08-22, SINGAPORE 408734
Model information
Model Name(s)
IMPAX Cardiovascular
Model Identifier(s)
12.0
About this record

Access comprehensive regulatory information for Agfa Healthcare IMPAX Cardiovascular Review Station Software in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016731 and owned by Agfa Healthcare N.V.. The device was registered on January 09, 2015.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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