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MIR Spirolab Spirometer and Pulse Oximeter - HSA Registration DE0010592

Access comprehensive regulatory information for MIR Spirolab 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 DE0010592 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.

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CLASS B
DE0010592
MIR Spirolab Spirometer and Pulse Oximeter
HSA Registration Number: DE0010592
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Product Description

Spirolab Spirometer and Pulse Oximeter is intended to be used by either a physician, respiratory therapist or technician. The device is intended to test lung function and can make: • spirometry testing in people of all ages, excluding infants and neonates • oximetry testing in people of all ages.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0010592
Registration Date
September 10, 2012
Change Notification Approval Date
December 15, 2020
Retention Due Date
September 09, 2025
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 SPIROLAB III SPIROLAB III & Oximeter SPIROLAB III (B/W) Spirolab Spirolab without turbine flowmeter Spirolab with one reusable turbine flowmeter Spirolab & Oximeter Spirolab with Oximeter but without turbine flowmeter Spirolab with Oximeter and with one reusable turbine flowmeter Calibration syringe 3L CD WinspiroPRO
Model Identifier(s)
910002 910004 910300 910302 910307 910310 910320 910650 910651 910655 911080 911080E0 911080E1 911081 911081E0 911081E1 919000 920100