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Sibelmed DATOSPIR Aira Spirometer - HSA Registration DE0508303

Access comprehensive regulatory information for Sibelmed DATOSPIR Aira Spirometer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508303 and owned by SIBEL S.A.U.. The device was registered on July 18, 2023.

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
DE0508303
Sibelmed DATOSPIR Aira Spirometer
HSA Registration Number: DE0508303
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Product Description

Measurement of lung flows and volumes for the diagnostic and control of respiratory diseases (Asthma, COPD, etc.)

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508303
Registration Date
July 18, 2023
Change Notification Approval Date
November 13, 2024
Retention Due Date
July 17, 2025
Product Owner
Short Name
SIBEL S.A.U.
Address
Rosellón 500 bajos 08026, BARCELONA, SPAIN
Registrant
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Importer
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Model Information
Model Name(s)
Pediatric Mouthpiece adapter Disposable mouthpieces Reusable mouthpieces Nose clip Disposable transducer Calibration syringe Disposable transducer Disposable mouthpieces Datospir Basic-T Plastic Mouthpiece Nose clip Bacterial-viral filter Datospir Aira D Datospir Aira F Datospir Aira T
Model Identifier(s)
1149 1555 1569 2692 3169 8290 8704 9037 9066 9152 9160 9698 9883 9884 9885