- Role
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- Date of registration
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EUDAMED last updated this device on May 19, 2026
08476270BPERBLKRZ9Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Peroxidazed 1 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 Sweden. 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 →00847627012395Basic 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 →08476270BPERBLKRZ9PX968MUDI 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)00847627012395
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 Sweden; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Jan 6, 2012 | Still on market |
| Bulgaria | Oct 6, 2020 | Still on market |
| Germany | Mar 2, 2012 | Still on market |
| EL | Jul 23, 2014 | Still on market |
| France | Dec 16, 2015 | Still on market |
| Italy | Mar 23, 2012 | Still on market |
| Lithuania | Sep 4, 2019 | Still on market |
| Latvia | Jul 19, 2018 | Still on market |
| Romania | Nov 29, 2012 | Still on market |
| Slovenia | Jun 20, 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.08476270BWASHBUF3QOn the marketPeroxidazed 108476270BPERBLKRZ9On the marketPeroxidazed 108476270BPERBLKRZ9On the marketPeroxidazed Diluent08476270BPERBLKRZ9On the marketPolymer Negative Control Serum (Mouse & Rabbit), 100mL8476270BNEGCNTZHOn the marketPolymer Negative Control Serum (Mouse & Rabbit), 25mL8476270BNEGCNTZHOn the market