- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Oct 24, 2025
843661029SE002015KVircell S.L is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Vircell, S.L. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08436610290401SE002(01)08436610290401
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUSPrimary placement in Spain; available across 1 country total.
Placed on the market in Spain; per-country availability dates not published.
ES-MF-000004099The 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.
843661029VRF00301R3On the marketVIRAPID® ROTA/ADENO/NORO GI/NORO GII Ag843661029VRC00601QBOn the marketVIRAPID® STREPTOCOCCUS GROUP A Ag843661029VRC00301PUOn the marketVircell, S.L843661029SE001015EOn the marketVIRCELL® ASPERGILLUS GALACTOMANNAN AG CONTROL843661029VEC00101GMOn the marketVIRCLIA® AUXILIARY REAGENTS843604032VCMAR01GUOn the marketCertificate health across this manufacturer's portfolio.
V13 112727 0005SupplementedV76 112727 0006IssuedNotified 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 →Notified 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 →