Singapore HSA registration DE0501941
Geratherm Respiratory Spirostik and Spirostik Blue
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 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.
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)
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B