- Role
- Country
- Date of registration
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EUDAMED last updated this device on Jun 2, 2026
B-06974785750389Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Influenza A&B/COVID-19 Antigen Combo Rapid Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Anhui Formaster Biosci Co., Ltd. . Placed on the EU market in Spain. 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 →06974785750389Basic 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-06974785750389IABC-1033UDI 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 →(01)06974785750389
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090601CORONAVIRUS / INFLUENZA - RT & POC1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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 Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Still on market |
CN-MF-000002305No 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-06974785750365On the marketCOC (Cocaine) Rapid Test (Saliva)B-06974785750525On the marketCOC (Cocaine) Rapid Test (Urine)B-06974785750440On the marketFOB (Human Occult Blood) Rapid Test (Feces)B-06974785750327On the marketH. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma)B-06974785750464On the market