Masimo Masimo W1 - HSA Registration DE0509287
Access comprehensive regulatory information for Masimo Masimo W1 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509287 and owned by Masimo Corporation. The device was registered on May 14, 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.
Masimo W1 is intended to be worn on the wrist for the spot-checking of ECG and other continuous parameters (e.g., pulse oximetry). The watch is intended to be used in hospital, hospital-type facilities, long-term care facilities, and home. Masimo W1 watch and the integrated Masimo W1 Module are indicated for patients with suspected heart conditions and health-conscious individuals. The Masimo W1 watch and the integrated Masimo W1 Module are indicated for the detection, display, recording, and transferring of a single lead ECG and determination of ECG parameters (e.g., Heart Rate, Atrial fibrillation) on adults. The Masimo W1 watch and the integrated Masimo W1 Module are indicated for non-invasive spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and respiration rate from the pleth (RRp) on adults.