- Role
- Country
- Date of registration
- Address
RO-MF-000023578LUMEA BxChip is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Themis Pathology. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Oct 31, 2025
5944759003BXC001B0000006MPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05944759003729
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
6 warnings recorded — scroll inside the panel to see all entries.
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.
Primary placement in Romania; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | Oct 30, 2025 | Still on market |
| Austria | Oct 30, 2025 | Still on market |
| Belgium | Oct 30, 2025 | Still on market |
| Bulgaria | Oct 30, 2025 | Still on market |
| Cyprus | Oct 30, 2025 | Still on market |
| Czechia | Oct 30, 2025 | Still on market |
| Germany | Oct 30, 2025 | Still on market |
| Denmark | Oct 30, 2025 | Still on market |
| Estonia | Oct 30, 2025 | Still on market |
| EL | Oct 30, 2025 | Still on market |
| Spain | Oct 30, 2025 | Still on market |
| Finland | Oct 30, 2025 | Still on market |
| France | Oct 30, 2025 | Still on market |
| Croatia | Oct 30, 2025 | Still on market |
| Hungary | Oct 30, 2025 | Still on market |
| Ireland | Oct 30, 2025 | Still on market |
| Iceland | Oct 30, 2025 | Still on market |
| Italy | Oct 30, 2025 | Still on market |
| Liechtenstein | Oct 30, 2025 | Still on market |
| Lithuania | Oct 30, 2025 | Still on market |
| Luxembourg | Oct 30, 2025 | Still on market |
| Latvia | Oct 30, 2025 | Still on market |
| Malta | Oct 30, 2025 | Still on market |
| Netherlands | Oct 30, 2025 | Still on market |
| Norway | Oct 30, 2025 | Still on market |
| Poland | Oct 30, 2025 | Still on market |
| Portugal | Oct 30, 2025 | Still on market |
| Sweden | Oct 30, 2025 | Still on market |
| Slovenia | Oct 30, 2025 | Still on market |
| Slovakia | Oct 30, 2025 | Still on market |
| Türkiye | Oct 30, 2025 | Still on market |
| XI | Oct 30, 2025 | 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.
05944759003729Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
5944759003BXC001B0000006MBxC 012.bUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
1 packaging level registered — each level carries its own UDI-DI.
05944759003729× 1 unitBase unit05944759003941× 50 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
W0599IVD GENERAL USE CONSUMABLE DEVICES - OTHERNo 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.No certificate specifically references this device's Basic UDI-DI.