- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jul 23, 2024
B-06438172403086NeoMass AAAC Plus Extraction Solution B 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.
06438172403086710011009FI-MF-000018281C-02-1172-794-22(01)06438172403086
5 warnings recorded — scroll inside the panel to see all entries.
Highly Flammable
Toxic if swallowed
Toxic to skin
Toxic if inhaled
Causes damage to organs
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.
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.
Primary placement in Finland; available across 1 country total.
Placed on the market in Finland; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01010499MULTIPLE CLIN. CHEM LAB REAGENTS - OTHERPrimary 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-06438172402010On the marketNEOMASS AAAC PLUSB-06438172403017On the marketNeoMass AAAC Plus dried blood spot (DBS) controlsB-06438172403024On the marketNeoMass AAAC Plus Internal standard - Labelled Acylcarnitines (ISTD - AC)B-06438172403048On the marketNeoMass AAAC Plus Internal Standard - Labelled Argininosuccinic Acid (ISTD - ASA)B-06438172403062On the marketNeoMass AAAC Plus Internal Standard - Labelled Succinylacetone (ISTD - SUAC)B-06438172403055On 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.