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Singapore HSA registration DE0509109

Medical Wearable Platform SDK-01

Singapore flagSingapore·CLASS B·VivaLNK, INC.·Registered March 26, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0509109
Registration Date
March 26, 2024
Retention Due Date
March 25, 2026
Product description
Medical Wearable Platform SDK-01 is intended to record, store and transfer electrocardiogram (ECG) and accelerometer data. The platform has the capability to provide Heart Rate, Respiratory Rate (RR), R-R Interval and Blood Pressure values. The ECG recorder Patch is an ambulatory, continuous recording Patch, intended for at home or hospital use, by clinicians or health professionals who intend to monitor their patient's physiological and health conditions for an extended period of time.
Product Owner
Name
VivaLNK, INC.
Short Name
VivaLNK, INC.
Address
51 E Campbell Ave, Suite 160, Campbell, California, 95008, UNITED STATES
Registrant
Name
BioD Medica Pte Ltd
Address
12 MARINA BOULEVARD, MARINA BAY FINANCIAL CENTRE, #17-00, SINGAPORE 018982
Importer
Name
BIOD MEDICA PTE LTD
Address
12 MARINA BOULEVARD, MARINA BAY FINANCIAL CENTRE, #17-00, SINGAPORE 018982
Model information
Model Name(s)
ECG Recorder Adhesive
Model Identifier(s)
VV3x0 VV3x0A
About this record

Access comprehensive regulatory information for Medical Wearable Platform SDK-01 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509109 and owned by VivaLNK, INC.. The device was registered on March 26, 2024.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B