- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jul 17, 2026
843661525GVS-B51N4Genvinset® HLA B51 48 test is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Blackhills Diagnostic Resources S.L.U.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08436615250103GVS-B51-48(01)08436615250103
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0106010401HLA-TYPING1 warning recorded — scroll inside the panel to see all entries.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Jul 17, 2026 | Still on market |
ES-MF-000001091The 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.
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 →No certificate specifically references this device's Basic UDI-DI.
8437016942GVS-B27LXOn the marketGenvinset® HLA B27v5 48 tests8437016942GVS-B27LXOn the marketGenvinset® HLA B51 24 test843661525GVS-B51N4On the marketGenvinset® HLA B57v5 24 testsB-08437016942673On the marketGenvinset® HLA B57v5 48 testsB-08437016942680On the marketGenvinset® HLA Behçet v5 24 tests8437016942GVS-B5CFOn the marketNo 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.