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EUDAMED last updated this device on May 19, 2026
08476270BLSABKE4plus Biotinylated Universal Goat Link 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 Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00847627008343 GU600HUS-MF-000034581(01)00847627008343
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.
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 Germany; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Feb 24, 2012 | Still on market |
| Spain | Oct 31, 2013 | Still on market |
| Sweden | May 13, 2022 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01029099IMMUNOCHEMISTRY REAGENTS - OTHERPrimary 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 →08476270BLSABKEOn the market4plus Biotinylated Goat Anti-Rabbit IgG08476270BLSABKEOn the market4plus Biotinylated Goat Anti-Rabbit IgG (Mouse and rat adsorbed)08476270BLSABKEOn the market4plus Biotinylated Universal Goat Link08476270BLSABKEOn the market4plus HRP Universal Detection08476270BLSABKEOn the market4plus Streptavidin HRP Label08476270BLSABKEOn the marketNo certificate specifically references this device's Basic UDI-DI.
No 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.