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EUDAMED last updated this device on May 19, 2026
8437013457Gentest001QKA1AT Genotyping Test Reagents is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Progenika Biopharma, S.A.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
084370134571011292320000(01)08437013457101
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0106010199MONOGENETIC DISORDERS TESTS - OTHER1 warning recorded — scroll inside the panel to see all entries.
Please check the Package Insert
ES-MF-000001005The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Spain; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
| Germany | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
| Portugal | — | Still on market |
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.
Certificate health across this manufacturer's portfolio.
V13 076212 0030ReissuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →