- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 26, 2026
5944759080VTHAVM25SPCB6JWHAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/plasma), caseta is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by VitroBioChem SRL. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05944759080072VT-HAVM-25RO-MF-000010877(01)05944759080072
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Romania; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | May 26, 2026 | Dec 31, 2030 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01021699RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHERPrimary 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 →No certificate specifically references this device's Basic UDI-DI.
5944759080VTFOB25FECPB62BOn the marketGiardia lamblia Ag (Feces)Rapid Test cassette Test rapid Giardia lamblia Ag (din materii fecale) caseta5944759080VTGIAG25FECB6XKOn the marketH.PYLORI ANTIGEN RAPID TEST CASSETTE ( FECES)5944759080VTHPG25STO1B6H5On the marketHELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)5944759080VTHPB25SPROB6HCOn the marketMulti-Line 12 Drugs Rapid Test Cassette (urine) TEST RAPID MULTIDROG 12 PARAMETRI (DIN URINA) CASETA5944759080VTMLD1225USB6V3On the marketMulti-Line 18 Drugs (urine) Test Cassette TEST RAPID MULTIDROG 18 PARAMETRI (DIN URINA) CASETA5944759080VTMLD1825USB6Y9On the marketNo 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.