- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 19, 2026
08476270BWASHBUF3QPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →TBS Automation Wash Buffer, 40X 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 →00847627014658Basic 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 →08476270BWASHBUF3QTWB946L2JUDI 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)00847627014658
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 15 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Feb 9, 2012 | Still on market |
| Austria | Feb 29, 2012 | Still on market |
| Belgium | Nov 16, 2018 | Still on market |
| Bulgaria | Sep 2, 2020 | Still on market |
| Czechia | Jun 1, 2015 | Still on market |
| Germany | Jan 6, 2015 | Still on market |
| EL | Mar 13, 2014 | Still on market |
| Spain | Jul 17, 2012 | Still on market |
| France | May 9, 2016 | Still on market |
| Hungary | Jan 30, 2015 | Still on market |
| Italy | Mar 30, 2012 | Still on market |
| Lithuania | Sep 4, 2019 | Still on market |
| Netherlands | May 9, 2014 | Still on market |
| Romania | Sep 29, 2017 | Still on market |
| Türkiye | Mar 29, 2013 | 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 marketTacha’s Automated Hematoxylin, 500mL08476270BCHEMATH6On the marketTBS Automation Wash Buffer, 20X08476270BWASHBUF3QOn the marketTris Buffer Saline (TBS) Plus, 10X08476270BWASHBUF3QOn the marketUniversal HRP Detection08476270BMACH421JCOn the marketUniversal Negative Control Serum8476270BNEGCNTZHOn the market