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US-MF-000048711PROSIGNA-002; PROSIGNA-003; PROSIGNA-004; PROSIGNA-010 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Veracyte, Inc. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 22, 2026
B-00850024414044Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00850024414044
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 France; available across 28 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Mar 10, 2022 | Dec 30, 2028 |
| Austria | Mar 10, 2022 | Dec 30, 2028 |
| Belgium | Mar 10, 2022 | Dec 30, 2028 |
| Cyprus | Mar 10, 2022 | Dec 30, 2028 |
| Germany | Mar 10, 2022 | Dec 30, 2028 |
| Denmark | Mar 10, 2022 | Dec 30, 2028 |
| Estonia | Mar 10, 2022 | Dec 30, 2028 |
| EL | Mar 10, 2022 | Dec 30, 2028 |
| Spain | Mar 10, 2022 | Dec 30, 2028 |
| Finland | Mar 10, 2022 | Dec 30, 2028 |
| Croatia | Mar 10, 2022 | Dec 30, 2028 |
| Hungary | Mar 10, 2022 | Dec 30, 2028 |
| Ireland | Mar 10, 2022 | Dec 30, 2028 |
| Iceland | Mar 10, 2022 | Dec 30, 2028 |
| Italy | Mar 10, 2022 | Dec 30, 2028 |
| Liechtenstein | Mar 10, 2022 | Dec 30, 2028 |
| Lithuania | Mar 10, 2022 | Dec 30, 2028 |
| Luxembourg | Mar 10, 2022 | Dec 30, 2028 |
| Latvia | Mar 10, 2022 | Dec 30, 2028 |
| Malta | Mar 10, 2022 | Dec 30, 2028 |
| Netherlands | Mar 10, 2022 | Dec 30, 2028 |
| Norway | Mar 10, 2022 | Dec 30, 2028 |
| Poland | Mar 10, 2022 | Dec 30, 2028 |
| Portugal | Mar 10, 2022 | Dec 30, 2028 |
| Romania | Mar 10, 2022 | Dec 30, 2028 |
| Sweden | Mar 10, 2022 | Dec 30, 2028 |
| Türkiye | Mar 10, 2022 | Dec 30, 2028 |
| XI | Mar 10, 2022 | Dec 30, 2028 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00850024414044Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-00850024414044PROSIGNA-002; PROSIGNA-003; PROSIGNA-004; PROSIGNA-010UDI 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.
W010699GENETIC TESTS - 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.