Pure Global
Singapore HSA registration DE0509731

WR Medical Heart Rate Variability (HRV) Acquire

Singapore flagSingapore·CLASS B·WR Medical Electronics Co·Registered September 04, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0509731
Registration Date
September 04, 2024
Retention Due Date
September 03, 2025
Product description
The Heart Rate Variability (HRV) Acquire device is intended to record and indicate the following parameters during autonomic testing maneuvers: • Expiratory pressure recording and display • Respiratory effort • Breathing Cue metronome • Heart rate via electrocardiography (ECG) • Non-invasive blood pressure from optional external device The HRV Acquire does not make a diagnosis or indicate by itself that any disease state exists. The HRV Acquire is not designed for self- monitoring of patients.
Product Owner
Name
WR Medical Electronics Co
Short Name
WR Medical Electronics Co
Address
1700 Gervals Avenue, Maplewood MN 55109, MN, UNITED STATES
Registrant
Name
DANMEDIK (S) PRIVATE LIMITED
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Importer
Name
DANMEDIK (S) PRIVATE LIMITED
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Model information
Model Name(s)
ECG Electrode Red Dot ECG cable, 10' ECG 3-lead pigtail w/ clips HRV, Chest Bellows WR Testworks, Neurological Testing Management Software HRV Acquire main unit HRV Acquire, Filtered Valsalva Hub and Tubing Filtered Mouthpiece
Model Identifier(s)
3214 5047 5048 5582 5620 5650 5815 5816
About this record

Access comprehensive regulatory information for WR Medical Heart Rate Variability (HRV) Acquire in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509731 and owned by WR Medical Electronics Co. The device was registered on September 04, 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