Singapore HSA registration DE0018223
OSATU Reanibex 300 AED/Manual Defibrillator
Singapore·CLASS C·OSATU S.Coop·Registered June 06, 2016Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0018223
- Registration Date
- June 06, 2016
- Retention Due Date
- June 05, 2025
Product description
The REANIBEX 300 is a portable, lightweight Defibrillator designed to carry out advanced monitoring and resuscitation functions in three operating modes: Manual Defibrillator, Automated Defibrillator and ECG Mode. The REANIBEX 300 is recommended for use by personnel trained in the use of the equipment and qualified in basic life support, advanced life support or defibrillation in hospital and out-of-hospital environments that meet the environmental conditions indicated in the user manual. When used in the Manual Defibrillator or ECG modes, the REANIBEX 300 should be used by medical personnel trained in advanced life support. Both the Automated and Manual defibrillator mode can be used with standard defibrillation electrodes only in adults and in children over 8 years of age or weighing over 25 kg (55 lbs). Both the Automated and Manual defibrillator mode can be used in children under 8 years of age or weighing less than 25 kg (55 lbs) with specific paediatric defibrillation electrodes.
Product Owner
- Name
- OSATU S.Coop
- Short Name
- OSATU S.Coop
- Address
- Edificio Zearrekobuelta, Subida de Areitio Nº 5, 48260 Ermua (Bizkaia), SPAIN
Registrant
- Address
- 2 KALLANG AVENUE, CT HUB, #05-04, SINGAPORE 339407
Importer
- Address
- 2 Kallang Avene, CT Hub, #05-04, SINGAPORE 339407
Model information
- Model Name(s)
- Reanibex 300 Reanibex 300 Reanibex 300 REANIBEX Data Manager Battery Pack Battery Pack
- Model Identifier(s)
- DIA 2348 DIA 2350 DIA 2356 DII 0020 A DIS 3000 A DIS 3100 A
About this record
Access comprehensive regulatory information for OSATU Reanibex 300 AED/Manual Defibrillator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018223 and owned by OSATU S.Coop. The device was registered on June 06, 2016.
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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