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Respironics Trilogy Evo - HSA Registration DE0505522

Access comprehensive regulatory information for Respironics Trilogy Evo in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505522 and owned by Respironics, Inc.. The device was registered on March 04, 2021.

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
DE0505522
Respironics Trilogy Evo
HSA Registration Number: DE0505522
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Product Description

The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional, home, and nonemergency transport settings for example wheelchair, or personal vehicle. It may be used for both invasive and non-invasive ventilation. The AVAPS-AE mode is intended for noninvasive use in adult and pediatric patients weighing over 10kg with Obstructive Sleep Apnea (OSA), Respiratory Insufficiency and Respiratory Failure.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0505522
Registration Date
March 04, 2021
Change Notification Approval Date
April 26, 2024
Retention Due Date
March 03, 2026
Product Owner
Short Name
Respironics, Inc.
Address
1001 Murry Ridge Lane, Murrysville, PA 15668, UNITED STATES
Registrant
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Address
25 LI HWAN TERRACE, GOLDEN HILL ESTATE, SINGAPORE 556953 17 KAKI BUKIT PLACE, EUNOS TECHPARK, #---, SINGAPORE 416195 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880 622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model Information
Model Name(s)
Trilogy Oxygen Input Quick-Connect Inserts, 2 pack Adapter 22 mm x 22 mm ODย ย ย ย ย ย ย ย  Adapter 22 mm x 15 mm ODย ย ย ย ย ย ย ย  Flexible trach adapter with 15 mm connectionย ย ย ย  MPV Circuit Support System MPV Disposable Circuit MPV replacement straw kit (10) Circuit, Disposable, 22mm, Non-Heated, Dual Limb (10) Circuit, Disposable, 15mm, Non-Heated, Dual Limb External Pulse Oximeter (Nonin XPOD) (10) Disposable Active Exhalation Valve External Flow Sensor with Cable, Adult/Pediatric External Flow Sensor with Cable, Pediatric/Infant (10) Circuit, Disposable, 15mm, Non-Heated, Passive (10) Circuit, Disposable, 22mm, Non-Heated, Passive (10) Circuit, Disposable, 15mm, Non-Heated, Active (10) Circuit, Disposable, 22mm, Non-Heated, Active External Flow Sensor Cable External Flow Sensor, Adult/Pediatric External Flow Sensor, Pediatric/Infant (10) Bacterial/Viral Filter (10) Dual Limb Active Exhalation Valve (10) Disposable Swivel Passive Exhalation Port Whisper Swivel II Packaged Angled replacement mouthpiece, 22 mm Trilogy Evo, O2 International Trilogy Evo, O2 International (Non-BT) Trilogy Evo International Trilogy Evo, International (Non-BT)
Model Identifier(s)
1040390 1044186 1044191 1073863 1102862 1102866 1118840 1127306 1127307 1129640 1131661 1132106 1132107 1132339 1132340 1132343 1132344 1134592 1134711 1134712 1135776 1139436 1139909 332113 FC06566 IN2100X15B IN2100X19 IN2110X15B IN2110X19