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EUDAMED last updated this device on May 27, 2026
B-06936155803712Rapid Anti-HEV-IgM Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by InTec PRODUCTS, INC.. Placed on the EU market in Bulgaria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06936155803712ITP091101-TC40(01)06936155803712
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105020505HEV ANTIBODY IGM4 warnings recorded — scroll inside the panel to see all entries.
For in vitro diagnostic use only. All positive results must be confirmed by an alternate method. Do not interchange reagents from one kit lot to another.
Follow the instructions for use and assay procedure carefully.
Treat all specimens as though potentially infectious. Wear gloves and protective clothing when handling specimens, and autoclave devices used for testing before disposal.
Do not use kit materials beyond their expiration dates
Primary placement in Bulgaria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| BulgariaPrimary placement | — | Still on market |
CN-MF-000023625Sterile
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 →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 →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 →B-06936155804641On the marketRapid Anti-H.Pylori TestB-06936155803569On the marketRapid Anti-HEV-IgM TestB-06936155807147On the marketRapid Anti-TB (Mycobacterium Tuberculosis) TestB-06936155803675On the marketRapid Anti-TB (Mycobacterium Tuberculosis) TestB-06936155804597On the marketRapid Dengue Duo (NS1 Ag & IgM/IgG Ab) TestB-06936155808373On the marketNo certificate specifically references this device's Basic UDI-DI.
No 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.