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EUDAMED last updated this device on Nov 28, 2025
57144640-fSW-000011-25Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →285040 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by SBO Hearing A/S. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →05714464167784Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →57144640-fSW-000011-25285040UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →(01)05714464167784
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y214599HEARING AIDS - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Denmark; available across 27 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Sep 19, 2025 | Still on market |
| Austria | Sep 19, 2025 | Still on market |
| Belgium | Sep 19, 2025 | Still on market |
| Bulgaria | Sep 19, 2025 | Still on market |
| Cyprus | Sep 19, 2025 | Still on market |
| Czechia | Sep 19, 2025 | Still on market |
| Germany | Sep 19, 2025 | Still on market |
| Estonia | Sep 19, 2025 | Still on market |
| EL | Sep 19, 2025 | Still on market |
| Spain | Sep 19, 2025 | Still on market |
| Finland | Sep 19, 2025 | Still on market |
| France | Sep 19, 2025 | Still on market |
| Croatia | Sep 19, 2025 | Still on market |
| Hungary | Sep 19, 2025 | Still on market |
| Ireland | Sep 19, 2025 | Still on market |
| Italy | Sep 19, 2025 | Still on market |
| Lithuania | Sep 19, 2025 | Still on market |
| Luxembourg | Sep 19, 2025 | Still on market |
| Latvia | Sep 19, 2025 | Still on market |
| Malta | Sep 19, 2025 | Still on market |
| Netherlands | Sep 19, 2025 | Still on market |
| Poland | Sep 19, 2025 | Still on market |
| Portugal | Sep 19, 2025 | Still on market |
| Romania | Sep 19, 2025 | Still on market |
| Sweden | Sep 19, 2025 | Still on market |
| Slovenia | Sep 19, 2025 | Still on market |
| Slovakia | Sep 19, 2025 | Still on market |
DK-MF-000001270No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.