- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Aug 22, 2023
59038907600OpaskiCB0590389076004559038907600OpaskiCB5903890760045(01)05903890760045
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12040199GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW010No certificate specifically references this device's Basic UDI-DI.
Primary placement in Poland; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | Aug 18, 2023 | Still on market |
| Bulgaria | Jun 2, 2025 | Still on market |
| Estonia | Jun 2, 2025 | Still on market |
| France | Aug 30, 2023 | Still on market |
| Italy | Aug 30, 2023 | Still on market |
| Romania | Jun 2, 2025 | Still on market |
PL-MF-000027229No 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.