- Organization name
- UDI-DI code
- Reference / catalog number
BE-MF-000024530Neptune Scanner/Neptune Software is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by D-tek s.a.. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Dec 16, 2025
5425023685013VUPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05425023685099
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Belgium; available across 17 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | Dec 16, 2025 | Still on market |
| Austria | Dec 16, 2025 | Still on market |
| Czechia | Dec 16, 2025 | Still on market |
| Germany | Dec 16, 2025 | Still on market |
| EL | Dec 16, 2025 | Still on market |
| Spain | Dec 16, 2025 | Still on market |
| France | Dec 16, 2025 | Still on market |
| Croatia | Dec 16, 2025 | Still on market |
| Hungary | Dec 16, 2025 | Still on market |
| Italy | Dec 16, 2025 | Still on market |
| Luxembourg | Dec 16, 2025 | Still on market |
| Malta | Dec 16, 2025 | Still on market |
| Netherlands | Dec 16, 2025 | Still on market |
| Portugal | Dec 16, 2025 | Still on market |
| Romania | Dec 16, 2025 | Still on market |
| Slovenia | Dec 16, 2025 | Still on market |
| Slovakia | Dec 16, 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.
05425023685099Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
5425023685013VUDIA1003 + DIA1001UDI 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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201020101AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)542502368BDDCHROMATIN6YOn the marketNDH Chromatin Dot for BDI542502368BDDCHROMATIN6YOn the marketNeptune Instrument5425023685006VXOn the marketSclero-Poly- Synthetase Profile 12 Ag Dot542502368BDPMSCLCNOn the marketSclero-Poly- Synthetase Profile 12 Ag Dot for BDI542502368BDDPMSCLLTOn the marketSclero-Poly- Synthetase Profile 8 Ag Dot542502368BDPMSCLCNOn the marketNo 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.