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DE-MF-000013321HL 1034230-1NADAL® PSA Test (CE0197) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by nal von minden GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 10, 2026
B-nvm-602003RSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-nvm-602003RS
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
1 warning 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 Germany; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Dec 31, 2027 |
| Austria | — | Dec 31, 2027 |
| Belgium | — | Dec 31, 2027 |
| Bulgaria | — | Dec 31, 2027 |
| Cyprus | — | Dec 31, 2027 |
| Czechia | — | Dec 31, 2027 |
| Denmark | — | Dec 31, 2027 |
| Estonia | — | Dec 31, 2027 |
| EL | — | Dec 31, 2027 |
| Spain | — | Dec 31, 2027 |
| Finland | — | Dec 31, 2027 |
| France | — | Dec 31, 2027 |
| Croatia | — | Dec 31, 2027 |
| Hungary | — | Dec 31, 2027 |
| Ireland | — | Dec 31, 2027 |
| Iceland | — | Dec 31, 2027 |
| Italy | — | Dec 31, 2027 |
| Liechtenstein | — | Dec 31, 2027 |
| Lithuania | — | Dec 31, 2027 |
| Luxembourg | — | Dec 31, 2027 |
| Latvia | — | Dec 31, 2027 |
| Malta | — | Dec 31, 2027 |
| Netherlands | — | Dec 31, 2027 |
| Norway | — | Dec 31, 2027 |
| Poland | — | Dec 31, 2027 |
| Portugal | — | Dec 31, 2027 |
| Romania | — | Dec 31, 2027 |
| Sweden | — | Dec 31, 2027 |
| Slovenia | — | Dec 31, 2027 |
| Slovakia | — | Dec 31, 2027 |
| Türkiye | — | Dec 31, 2027 |
| XI | — | Dec 31, 2027 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-nvm-602003RSBasic 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-nvm-602003RS602003UDI 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.
W0102160202PSA - RT & POCB-nvm-252003N-20UROn the marketNADAL® Norovirus GI/GII TestB-nvm-920002T7On the marketNADAL® pH TestB-nvm-194002T8On the marketNADAL® RSV TestB-nvm-491905N-206EOn the marketNADAL® Strep A plus Test4065384STA1OPS4N1GXEWOn the marketNADAL® Strep A Plus TestB-nvm-222907N-20YROn the marketCertificate health across this manufacturer's portfolio.
IX 1034230-2IssuedHX 1034230-1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →No certificate specifically references this device's Basic UDI-DI.