Singapore HSA registration DE0504129
Flexicare Single Use Resuscitator
Singapore·CLASS B·FlexiCare Medical Ltd·Registered February 19, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0504129
- Registration Date
- February 19, 2020
- Retention Due Date
- February 18, 2026
Product description
Flexicare’s single use manual Resuscitator is intended for use on patients requiring artificial ventilation or ventilatory support in healthcare settings and emergency environments. Supplementary oxygen (O2) is delivered when connected to an O2 source. End tidal carbon dioxide (EtCO2) monitoring and application of aerosolised drugs from a metered-dose inhaler (MDI) is possible via designated ports. Available in three sizes: Adult (>30kg), Paediatric (10-30kg) and Infant (<10kg).
Product Owner
- Short Name
- FlexiCare Medical Ltd
- Address
- Cynon Valley Business Park, Mountain Ash, Rhondda Cynon Taff, CF45 4ER, UNITED KINGDOM
Registrant
- Address
- 17 KAKI BUKIT PLACE, EUNOS TECHPARK, SINGAPORE 416195
Importer
- Address
- 17 KAKI BUKIT PLACE, EUNOS TECHPARK, #---, SINGAPORE 416195
Model information
- Model Name(s)
- Adult Single Use Resuscitator with Pressure Relief 60cmH20 and Mask Size 5 Adult Single Use Resuscitator with Pressure Relief 60cmH20 + Mask Size 5 + Manometer Adult Single Use Resuscitator with Pressure Relief 60cmH20 + Mask Size 5 + Adjustable PEEP Valve Adult Single Use Resuscitator without Pressure Relief + Mask Size 5 Adult Single Use Resuscitator without Pressure Relief No Strap + Mask Size 5 Adult Single Use Resuscitator + Pressure Relief 40cmH20 + Mask Size 5 Paediatric Single Use Resuscitator + Pressure Relief 40cmH20 Mask Size 2 + Mask Size 1 Round Paediatric Single Use Resuscitator + Pressure Relief 40cmH20 Mask Size 2+Mask Size 1 Round Manometer Paediatric Single Use Resuscitator+Pressure Relief 40cmH20 Mask Size 2+Mask Size 1 Round+PEEP Valve Paediatric Single Use Resuscitator + Pressure Relief 40cmH20 + Mask Size 3 Infant Single Use Resuscitator + Pressure Relief 40cmH20 + Mask Size 1 + Mask Size 0 Round Infant Single Use Resuscitator + Pressure Relief 40cmH20 + Mask Size 1 +Mask Size 0 Round +Manometer Infant Single Use Resuscitator + Pressure Relief 40cmH20 +Mask Size 1 +Mask Size 0 Round +PEEP Valve
- Model Identifier(s)
- 038-71-940 038-71-941 038-71-942 038-71-943 038-71-944 038-71-945 038-72-940 038-72-941 038-72-942 038-72-946 038-73-940 038-73-941 038-73-942
About this record
Access comprehensive regulatory information for Flexicare Single Use Resuscitator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504129 and owned by FlexiCare Medical Ltd. The device was registered on February 19, 2020.
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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