Pure Global

MIR SPIRODOC spirometer and pulse oximeter - HSA Registration DE0010593

Access comprehensive regulatory information for MIR SPIRODOC 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 DE0010593 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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0010593
MIR SPIRODOC spirometer and pulse oximeter
HSA Registration Number: DE0010593
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The SPIRODOC spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician. The device is intended to test lung function and can make: โ€ข spirometry testing in people of all ages, excluding infants and neonates โ€ข oximetry testing in people of all ages.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
HSA Product Code
HSAMDB00102
HS Code
90200000
Registration Information
Registration Number
DE0010593
Registration Date
September 10, 2012
Change Notification Approval Date
July 06, 2022
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 Adult Reusable Plastic Mouthpiece Plastic Mouthpiece, Reusable, Pediatric Plastic Noseclip SPIRODOC Spirodoc without turbine flowmeter Spirodoc with one reusable turbine flowmeter Oximeter SPIRODOC & Oximeter Spirodoc with Oximeter but without turbine flowmeter Spirodoc with Oximeter and with one reusable turbine flowmeter Calibration syringe 3L CD WinspiroPRO
Model Identifier(s)
910002 910004 910300 910302 910307 910310 910320 910600 910600E0 910600E1 910606E 910610 910610E0 910610E1 919000 920100