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Singapore HSA registration DE0506841

Hill-Rom Volara™ System PVL1

Singapore flagSingapore·CLASS B·Hill-Rom Services Pte. Ltd.·Registered May 04, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0506841
Registration Date
May 04, 2022
Change Notification Approval Date
June 23, 2023
Retention Due Date
May 03, 2026
Product description
The Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with an oxygen supply. The Volara™ System is intended to deliver therapy to adults and children over the age of 2 in the acute care setting. The Volara™ System is intended to deliver therapy to adults and children over the age of 5 in the home care setting.
Product Owner
Name
Hill-Rom Services Pte. Ltd.
Short Name
Hill-Rom Services Pte. Ltd.
Address
1 YISHUN AVENUE 7, SINGAPORE 768923
Registrant
Name
Hill-Rom Services Pte. Ltd.
Address
1 YISHUN AVENUE 7, SINGAPORE 768923
Importer
Name
HILL-ROM SERVICES PTE. LTD. WELCH ALLYN SINGAPORE PTE. LTD.
Address
1 YISHUN AVENUE 7, #00-00, SINGAPORE 768923 1 YISHUN AVENUE 7, #00-00, SINGAPORE 768923
Model information
Model Name(s)
VOLARA P.CIRCUIT KIT VOLARA P.CIRCUIT 5KIT HC VOLARA P.CIRCUIT KIT AC VOLARA P.CIRCUIT 5KIT AC VOLARA,AC,SINGAPORE VOLARA,AC,CHINA VOLARA, HC,SINGAPORE VOLARA, HC,CHINA VOLARA CN P.CIRCUIT 5KIT HC VOLARA CN P.CIRCUIT 5KIT AC VOLARA CN P.CIRCUIT KIT HC VOLARA CN P.CIRCUIT KIT AC VOLARA SYSTEM,AC,CHINA VOLARA SYSTEM,AC,SINGAPORE VOLARA SYSTEM,HC,CHINA VOLARA SYSTEM,HC,SINGAPORE
Model Identifier(s)
M08085 M08270 M08473 M08474 M08946 M08947 M08948 M08949 M08957 M08958 M08959 M08960 PVL1ACCN PVL1ACSG PVL1HCCN  PVL1HCSG
About this record

Access comprehensive regulatory information for Hill-Rom Volara™ System PVL1 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506841 and owned by Hill-Rom Services Pte. Ltd.. The device was registered on May 04, 2022.

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