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CH-MF-000024251SBAS Software is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Smart Blood Analytics Swiss SA. Placed on the EU market in Slovenia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jan 6, 2025
7649996089SBASRCPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07649996089335
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
1. The final patient diagnosis shall always be determined by the responsible physician based on all available physical findings, patients’ anamneses, symptoms and results of other diag-nostic tests. The information provided by the software is intended to support the determi-nation of the diagnosis. 2. The use of SBAS Software is not allowed without consideration for the symptoms of a patient and their medical history. The SBAS Software should also not be used for screening purposes. 3. The SBAS Software can only be used if biological sex, age and a minimum of 30 blood test parameters from the List of blood parameters are available 4. The SBAS Software can only predict the disease that is available in its database. All the available diseases are listed in the List of diseases available in Annex 2. 5. The SBAS Software is not designed to be used on healthy patients. The use on healthy patients will provide non-relevant information.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Slovenia; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| SloveniaPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
07649996089335Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
7649996089SBASRCSBAS SoftwareUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSESCertificate health across this manufacturer's portfolio.
MDR-006SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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