Singapore HSA registration DE0010594
MIR Spirobank II Spirometer and Pulse Oximeter
Singapore·CLASS B·MIR Srl (Medical International Research)·Registered September 10, 2012Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Anaesthesiology
Registration information
- Registration Number
- DE0010594
- Registration Date
- September 10, 2012
- Change Notification Approval Date
- March 12, 2021
- Retention Due Date
- September 09, 2025
Product description
The SPIROBANK II spirometer and pulse oximeter is intended to be used by a physician, by a licensed healthcare professional or by a patient under the instruction of a physician or of a licensed healthcare professional. The device is intended to test lung function and can make spirometry testing in adult and pediatric patients, excluding infants and neonates, oximetry testing in people of all ages. It can be used in hospital setting, physician's office, factory, pharmacy.
Product Owner
- Short Name
- MIR Srl
- Address
- Via del Maggiolino, 125, 00155 Roma, ITALY
Registrant
- Address
- 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Importer
- Address
- 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Model information
- Model Name(s)
- Reusable Turbine FlowMir DISPOSABLE Turbine flow meter Paper Mouthpiece, Disposable, Adult Bacterial/Viral Filter Plastic Mouthpiece, Reusable, Adult Plastic Mouthpiece, Reusable, Pediatric Plastic Noseclip Spirobank II Advanced Spirometer Spirobank II Advanced Spirometer without turbine flowmeter Spirobank II Advanced Spirometer with one reusable turbine flowmeter Spirobank II Basic Spirometer Spirobank II Basic Spirometer without turbine flowmeter Spirobank II Basic Spirometer with one reusable turbine flowmeter Spirobank II Advanced Spirometer & Oximeter Spirobank II Advanced Spirometer & Oximeter without turbine flowmeter Spirobank II Advanced Spirometer & Oximeter with one reusable turbine flowmeter Spirobank II Advanced Smart Spirometer Spirobank II Advanced Smart Spirometer without turbine flowmeter Spirobank II Advanced Smart Spirometer with one reusable turbine flowmeter Spirobank II Advanced Smart Spirometer & Oximeter Spirobank II Advanced Smart Spirometer & Oximeter without turbine flowmeter Spirobank II Advanced Smart Spirometer & Oximeter with one reusable turbine flowmeter Calibration syringe 3L CD WinspiroPRO
- Model Identifier(s)
- 910002 910004 910300 910302 910307 910310 910320 911020 911020E0 911020E1 911021 911021E0 911021E1 911025 911025E0 911025E1 911028 911028E0 911028E1 911029 911029E0 911029E1 919000 920100
About this record
Access comprehensive regulatory information for MIR Spirobank II Spirometer and Pulse Oximeter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0010594 and owned by MIR Srl (Medical International Research). The device was registered on September 10, 2012.
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