- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 26, 2026
3770011742ASVIH0501002Uautotest VIH® 2nd GENERATION is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class D. Manufactured by AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05903205791436AS-VIH-011(01)05903205791436
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090302HIV 1 / 2 - RT & POC1 warning recorded — scroll inside the panel to see all entries.
Buffer Warning: contains Proclin (≥0.0015%), which may cause skin allergies.
FR-MF-00001588940540The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Poland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary 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 →Certificate health across this manufacturer's portfolio.
40028Supplemented40540IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →3770011742ASVIH0501002UOn the marketautotest VIH® 2nd GENERATION3770011742ASVIH0501002UOn the marketautotest VIH® 2nd GENERATION3770011742ASVIH0501002UOn the marketautotest VIH® 2nd GENERATION3770011742ASVIH0501002UOn the marketCANNABIS ALL INB-03770011742844On the marketCOV-GRIPB-03770011742073On the market