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Bionet Cardio7 - HSA Registration DE0502794

Access comprehensive regulatory information for Bionet Cardio7 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502794 and owned by BIONET CO., LTD.. The device was registered on February 21, 2019.

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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CLASS B
DE0502794
Bionet Cardio7
HSA Registration Number: DE0502794
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Product Description

The Cardio7 is intended to acquire, analyse, display and record electrocardiographical information from adult and paediatric populations. The Cardio7 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professionalโ€™s facility.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0502794
Registration Date
February 21, 2019
Retention Due Date
February 20, 2026
Product Owner
Short Name
BIONET CO., LTD.
Address
11F, E AND C DREAM TOWER III,, 197-33, GURO-DONG, GURO-GU,, KOREA, REPUBLIC OF
Registrant
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #04-02, SINGAPORE 408734
Importer
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #04-02, SINGAPORE 408734
Model Information
Model Name(s)
ECG Patient Cable (S) Cardio7 ECG Cart
Model Identifier(s)
152600-019000 Cardio7 ECG Cart