- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Aug 2, 2023
843604032VCLTS-CL012MVIRCLIA® LOTUS 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.
08436040328286VCLTS-CL(01)08436040328286
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0204INFECTIOUS IMMUNOLOGY INSTRUMENTS2 warnings recorded — scroll inside the panel to see all entries.
Primary 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 →Certificate 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 →843604032VCMAR-EDP01FTOn the marketVIRCLIA® AUXILIARY REAGENTS-W1843604032VCMAR-W101QXOn the marketVIRCLIA® EXTRACTION SOLUTION843661029VCES001014AOn the marketVIRCLIA® STOOL COLLECTION SET843661029VCCO00101ZHOn the marketVIRCLIA® STOOL PLUNGER FILTER843661029VCPF001014UOn the marketWASH BUFFER FOR ELISA KITS843604032B000101CPOn the marketNo certificate specifically references this device's Basic UDI-DI.