- Role
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- Address
CN-MF-000010710Strep B Rapid Test Cassette is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Hangzhou Alltest Biotech.Co.,Ltd.. 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 11, 2026
B-ISB-502SCPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-ISB-502SC
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
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 31 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | May 26, 2026 | Dec 31, 2028 |
| Austria | May 26, 2026 | Dec 31, 2028 |
| Belgium | May 26, 2026 | Dec 31, 2028 |
| Bulgaria | May 26, 2026 | Dec 31, 2028 |
| Cyprus | May 26, 2026 | Dec 31, 2028 |
| Czechia | May 26, 2026 | Dec 31, 2028 |
| Denmark | May 26, 2026 | Dec 31, 2028 |
| Estonia | May 26, 2026 | Dec 31, 2028 |
| EL | May 26, 2026 | Dec 31, 2028 |
| Spain | May 26, 2026 | Dec 31, 2028 |
| Finland | May 26, 2026 | Dec 31, 2028 |
| France | May 26, 2026 | Dec 31, 2028 |
| Croatia | May 26, 2026 | Dec 31, 2028 |
| Hungary | May 26, 2026 | Dec 31, 2028 |
| Ireland | May 26, 2026 | Dec 31, 2028 |
| Iceland | May 26, 2026 | Dec 31, 2028 |
| Italy | May 26, 2026 | Dec 31, 2028 |
| Liechtenstein | May 26, 2026 | Dec 31, 2028 |
| Lithuania | May 26, 2026 | Dec 31, 2028 |
| Luxembourg | May 26, 2026 | Dec 31, 2028 |
| Latvia | May 26, 2026 | Dec 31, 2028 |
| Malta | May 26, 2026 | Dec 31, 2028 |
| Netherlands | May 26, 2026 | Dec 31, 2028 |
| Norway | May 26, 2026 | Dec 31, 2028 |
| Poland | May 26, 2026 | Dec 31, 2028 |
| Portugal | May 26, 2026 | Dec 31, 2028 |
| Romania | May 26, 2026 | Dec 31, 2028 |
| Sweden | May 26, 2026 | Dec 31, 2028 |
| Slovenia | May 26, 2026 | Dec 31, 2028 |
| Slovakia | May 26, 2026 | Dec 31, 2028 |
| XI | May 26, 2026 | Dec 31, 2028 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-ISB-502SCBasic 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-ISB-502SCISB-502UDI 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.
W0105090104STREP. B - RT & POCCertificate health across this manufacturer's portfolio.
V76 095123 0019SupplementedNotified 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.
V76 095123 0020SupplementedNotified 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.
EU-QMS-FI-08820-800081-2026IssuedNotified 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.
EU-TDA-FI-51326-800081-2026IssuedNotified 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.
EU-QMS-FI-08820-800081-2026IssuedNotified 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.
CN26/00001622IssuedNotified 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 →B-06936983100533On the marketStrep A Rapid TestB-06970277510479On the marketStrep A Rapid Test CassetteB-06936983188661On the marketStrep B Rapid Test Dipstick Cardiac Troponin T Test CassetteB-ISB-501SAOn the marketStylo test de grossesseB-03664756002953On the marketStylo test de grossesseB-03615370003932On the marketNo certificate specifically references this device's Basic UDI-DI.