- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 27, 2026
B-06936155803484ONE STEP Pregnancy (hCG) 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.
06936155803484ITP04002-DS50(01)06936155803484
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160302HCG - RT & POC5 warnings recorded — scroll inside the panel to see all entries.
CW011CW010CW009CW007CW032CN-MF-000023625No 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.Primary placement in Bulgaria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| BulgariaPrimary placement | Still on market |
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.
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-06936155806997On the marketONE STEP Opiate (OPI/Morphine) TestB-06936155806867On the marketONE STEP Phencyclidine (PCP) TestB-06936155806935On the marketONE STEP Pregnancy (hCG) TestB-06936155803576On the marketONE STEP Tramadol (TRA) TestB-06936155803613On the marketONE STEP Tramadol (TRA) TestB-06936155806980On the marketNo certificate specifically references this device's Basic UDI-DI.