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US-MF-000034581Dewax Solution Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Biocare Medical. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 18, 2026
08476270BDEWAXH2Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00847627031846
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 Italy; available across 14 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Mar 18, 2021 | Still on market |
| Bulgaria | May 17, 2021 | Still on market |
| Czechia | Mar 10, 2022 | Still on market |
| Germany | May 7, 2021 | Still on market |
| EL | Feb 25, 2022 | Still on market |
| France | Mar 2, 2022 | Still on market |
| Hungary | May 19, 2023 | Still on market |
| Ireland | Mar 31, 2022 | Still on market |
| Latvia | Mar 4, 2022 | Still on market |
| Netherlands | May 20, 2022 | Still on market |
| Poland | Sep 15, 2022 | Still on market |
| Romania | Jan 20, 2022 | Still on market |
| Sweden | Mar 26, 2021 | Still on market |
| Türkiye | May 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.
00847627031846Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
08476270BDEWAXH2OPRI6004KT60 UDI 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.
W01029099IMMUNOCHEMISTRY REAGENTS - OTHERNo certificate specifically references this device's Basic UDI-DI.
No 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.