- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 22, 2026
B-697424646MON003MZ67Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Monkeypox Virus Antigen Rapid Test(Whole blood/Serum/Plasma) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by SAFECARE BIOTECH (HANGZHOU) CO., LTD.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →D-697424646MON003MZ67Basic 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 →B-697424646MON003MZ67MON Ag-4012UDI 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 →D-697424646MON003MZ67
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105099008MONKEYPOX VIRUS / MPOX RT & POCSterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market |
CN-MF-000019109No 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.B-697424646MON000MT5COn the marketMonkeypox Virus Antigen Rapid Test(Serum/Plasma)B-697424646MON004N343On the marketMonkeypox Virus Antigen Rapid Test(Swab)B-697424646MON005N54COn the marketMonkeypox Virus IgG/IgM Rapid Test(Serum/Plasma)B-697424646MON002MX5WOn the marketMonkeypox Virus IgG/IgM Rapid Test(Whole blood/Serum/Plasma)B-697424646MON001MV5MOn the marketMorphine Heroin(MOR) Rapid Test (Urine)B-697424646MOR001NR74On the market