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EUDAMED last updated this device on May 12, 2026
B-10608337001669OraQuick TEST HIV PENTRU AUTOTESTARE is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List A. Manufactured by OraSure Technologies, Inc.. Placed on the EU market in Bulgaria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
106083370016691001-0627US-MF-000009941DGM-585DGM-586(01)10608337001669
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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.
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 Bulgaria; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| BulgariaPrimary placement | — | Still on market |
| Romania | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090302HIV 1 / 2 - RT & POCPrimary 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.
B-00608337001273On the marketOraQuick SAMOTEST NA HIVB-10608337001065On the marketOraQuick SAMOTEST NA HIVB-00608337001068On the marketOraQuick TEST HIV PENTRU AUTOTESTAREB-00608337001662On the marketOraQuick® HCV Rapid Antibody Test Kit ControlsB-00608337000528On the marketTest OraQuick NA OBECNOŚĆ WIRUSA HIV DO SAMODZIELNEGO WYKONANIAB-10608337001676On 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.