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EUDAMED last updated this device on Jul 24, 2026
B-07640164860176Newfoundland Strep A Self-test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by PRIMA Lab SA. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07640164860176880060-xCH-MF-000034473D1408400052(01)07640164860176
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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 6 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Sep 1, 2023 | Still on market |
| Austria | Sep 1, 2026 | Still on market |
| Belgium | Sep 1, 2026 | Still on market |
| Spain | Sep 1, 2026 | Still on market |
| Netherlands | Sep 1, 2026 | Still on market |
| Portugal | Sep 1, 2026 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01021111ANTI-STREPTOCOCCAL SCREENINGPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
D1408400113SupplementedNotified 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.