Singapore HSA registration DE0502794
Bionet Cardio7
Singapore·CLASS B·BIONET CO., LTD.·Registered February 21, 2019Device 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 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 professional’s facility.
Product Owner
- Name
- BIONET CO., LTD.
- 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
About this record
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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