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Geratherm Respiratory Spirostik and Spirostik Blue - HSA Registration DE0501941

Access comprehensive regulatory information for Geratherm Respiratory Spirostik and Spirostik Blue in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501941 and owned by Geratherm Respiratory GmbH. The device was registered on July 24, 2018.

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
DE0501941
Geratherm Respiratory Spirostik and Spirostik Blue
HSA Registration Number: DE0501941
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Product Description

Spirostik and Spirostik Blue are PC-connected spirometers, intended to identify the static and dynamic lung volume in pulmonary function testing in a clinical setting and by established physicians. For use in the mouth, nose, upper throat area, trachea and lungs. Software permits measurements for spirometry, flow / volume and MVV as well as pre / post examinations and trend analysis. Can carry out examination: Broncoprovocation. Pulmonary function examinations can be carried out for diagnosing, monitoring of process, screening and assessing the severity of pulmonary diseases. Includes: Obstructive diseases • Dyspnea (shortness of breath) or coughing when at rest as well as under stress • Bronchial asthma • Chronic obstructive pulmonary disease (COPD) • Pulmonary emphysema Restrictive diseases • Interstitial lung diseases • Pulmonary fibrosis • Impairments of the chest • Neuromuscular diseases Allergy diagnosis.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0501941
Registration Date
July 24, 2018
Change Notification Approval Date
February 07, 2023
Retention Due Date
July 23, 2025
Product Owner
Short Name
Geratherm Respiratory GmbH
Address
Kasernenstraße 4, 97688 Bad Kissingen, GERMANY
Registrant
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #04-02, SINGAPORE 408734
Importer
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #04-02, SINGAPORE 408734
Model Information
Model Name(s)
Blueflow Set for BVF, Dispossable Spiraflow and Softclip Set Spirostik Spirostik Blue Blueflow Set, Reusable Blueflow Set, Dispossable
Model Identifier(s)
180768 340968 (10.401) 361333 (40.001) 571442 (40.075) 860490 (40.060) 879996 (40.050)