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EUDAMED last updated this device on Jul 23, 2024
B-06438172403093NeoMass AAAC Plus Eluent Solution is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by Labsystems Diagnostics Oy. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06438172403093710011010(01)06438172403093
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01010499MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER5 warnings recorded — scroll inside the panel to see all entries.
Flammable liquid
Harmful if swallowed
Harmful in contact with skin
Harmful if inhaled
Causes serious eye irritation
FI-MF-000018281C-02-1172-794-22Primary placement in Finland; available across 1 country total.
Placed on the market in Finland; per-country availability dates not published.
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.
B-06438172166011On the marketMYCOPLASMA PNEUMONIAE IgG EIAB-06438172165014On the marketMycoplasma pneumoniae IgM EIAB-06438172167018On the marketNeoMass AAAC 3.0B-06438172402010On the marketNEOMASS AAAC PLUSB-06438172403017On the marketNeoMass AAAC Plus dried blood spot (DBS) controlsB-06438172403024On 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.