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EUDAMED last updated this device on Jun 3, 2026
B-06974785750464H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma) 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.
06974785750464B-06974785750464IHP-5013(01)06974785750464
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105010402H. PYLORI ANTIBODY ASSAYS1 warning recorded — scroll inside the panel to see all entries.
CW010No 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 Antigen Rapid Test (Feces)B-06974785750341On the market