- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 19, 2026
08476270BOPAGRETYXPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Antigen Retrieval 1 (AR1), high pH is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Biocare Medical. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →00847627031860Basic 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 →08476270BOPAGRETYXOPRI6006T60 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 →(01)00847627031860
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01029099IMMUNOCHEMISTRY REAGENTS - OTHERSterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 14 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Mar 18, 2021 | Still on market |
| Bulgaria | May 17, 2021 | Still on market |
| Czechia | Mar 10, 2022 | Still on market |
| Germany | May 7, 2021 | Still on market |
| EL | Feb 25, 2022 | Still on market |
| France | Mar 2, 2022 | Still on market |
| Hungary | May 19, 2023 | Still on market |
| Ireland | Mar 31, 2022 | Still on market |
| Latvia | Mar 4, 2022 | Still on market |
| Netherlands | May 20, 2022 | Still on market |
| Poland | Sep 15, 2022 | Still on market |
| Romania | Jan 20, 2022 | Still on market |
| Sweden | Mar 26, 2021 | Still on market |
| Türkiye | May 16, 2025 | Still on market |
US-MF-000034581No 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.08476270BLSABKEOn the market4plus Universal AP Detection08476270BLSABKEOn the marketAntigen Decloaker, 10X08476270BAGRETFSOn the marketAntigen Retrieval 2 (AR2), low pH08476270BOPAGRETYXOn the marketAntigen Retrieval Chamber High Voltage08476270BARCLNOn the marketAqua DePar, 10X08476270BDEPARFKOn the market