Smart Blood Analytics Swiss SA
Switzerland CH-MF-000024251 Last updated 21 Oct 2026
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- Devices
- 2
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
VIRUS vs. BACTERIA Ref VIRUS vs. BACTERIA
SBAS Software Ref SBAS Software
EUDAMED certificates
SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ 1304 1 certificate
- MDR-006 Supplemented
Quality management system EU MDR
- Issued
- 15 Apr 2024
- Expires
- 26 Dec 2028
- Reason
- Add device or group
Related companies
Authorised representatives
Notified bodies
About
Smart Blood Analytics is using advanced algorithms to provide a list of the most probable diseases based on the individuals’ blo..
What Smart Blood Analytics Swiss SA makes
Smart Blood Analytics Swiss SA develops diagnostic software that analyzes blood samples to generate a list of probable diseases, distinguishing between viral and bacterial infections. The software, named SBAS, processes biological data to assist in identifying potential conditions based on laboratory results.
The company’s products fall under EU Class IIa medical devices and are registered in the EU’s eudamed database. The manufacturer is based in Switzerland.
Frequently asked questions
What types of medical devices does Smart Blood Analytics Swiss SA manufacture?
Smart Blood Analytics Swiss SA develops diagnostic software called SBAS, which analyzes blood sample data to generate a list of probable diseases. The software helps distinguish between viral and bacterial infections by processing laboratory results with advanced algorithms. These devices are designed to assist healthcare professionals in identifying potential conditions based on biological data.
Where is Smart Blood Analytics Swiss SA based?
The company is headquartered in Switzerland. This location reflects its focus on developing innovative diagnostic tools, likely leveraging Switzerland’s strong reputation for precision engineering and medical technology.
Which regulatory registries list Smart Blood Analytics Swiss SA’s devices?
The company’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This inclusion ensures transparency and compliance with EU regulatory requirements for Class IIa devices.
How are Smart Blood Analytics Swiss SA’s devices classified under EU regulations?
The company’s products fall under EU Class IIa medical devices. This classification is determined by the risk associated with the device—Class IIa devices pose a moderate risk and require compliance with specific EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements to ensure safety and performance.
Information
- Country
- Switzerland
- Address
- 25, Höschgasse, Zürich, Switzerland
- Website
- www.smartbloodanalytics.com
- [email protected]
- PRRC contact
- Ziga Osterc
- EUDAMED SRN
- CH-MF-000024251