Singapore HSA registration DE0503480
Capsule Technologie SmartLinx Vitals Plus
Singapore·CLASS C·Capsule Technologie SAS·Registered August 15, 2019Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0503480
- Registration Date
- August 15, 2019
- Change Notification Approval Date
- April 06, 2020
- Retention Due Date
- August 14, 2025
Product description
The SmartLinx Vitals Plus patient monitoring system is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.
Product Owner
- Short Name
- Capsule Technologie SAS
- Address
- 76-78, Avenue de France, 75013, Paris, FRANCE
Registrant
- Address
- 4 BATTERY ROAD, BANK OF CHINA BUILDING, #25-01, SINGAPORE 049908
Importer
- Address
- 2 Kallang Avene, CT Hub, #05-04, SINGAPORE 339407
Model information
- Model Name(s)
- SmartLinx Neuron 2 SmartLinx Neuron 2 -Dual Battery Dock SmartLinx Vitals Plus- Alarm Hub SmartLinx Vitals Plus Covidien Filac 3000 -Temperature Module Nellcor- Standalone Oximetry Module SmartLinx Vitals Plus SmartLinx Vitals Plus Roll Stand Exergen TAT-5000S Infrared Temporal Artery Thermometer
- Model Identifier(s)
- DC-NU2-UMPC SL-NU2-DUBAT SL-VP-ALARM-HUB SL-VP-BPAP-HW SL-VP-FILAC SL-VP-NELLSAM-HW SL-VP-NIBPAH-MON-HW SL-VP-ROLLSTAND SL-VP-TATSCAN
About this record
Access comprehensive regulatory information for Capsule Technologie SmartLinx Vitals Plus in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503480 and owned by Capsule Technologie SAS. The device was registered on August 15, 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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