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Capsule Technologie SmartLinx Vitals Plus - HSA Registration DE0503480

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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CLASS C
DE0503480
Capsule Technologie SmartLinx Vitals Plus
HSA Registration Number: DE0503480
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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.

Device 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 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