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EUDAMED last updated this device on Jun 15, 2023
B-08719327116111MeningoFinder® 2SMART is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by PathoFinder B.V.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08719327116111PF1200-2S(01)08719327116111
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105011103STREP. A DETECTION BY NA REAGENTSW0105011105STREP. PNEUMONIAE DETECTION BY NA REAGENTSW0105060403CRYPTOCOCCUS - NA REAGENTSW0105011503E. COLI DETECTION BY NA REAGENTSW0105011611NEISSERIA MENINGITIDIS - NA REAGENTSW0105011610HAEMOPHILUS INFLUENZAE - NA REAGENTSW0105011305LISTERIA DETECTION BY NA REAGENTSW0105040524HHV-6,7,8 - NA REAGENTSW0105040205CMV - NA REAGENTSW0105040403EBV - NA REAGENTSW01050409041 warning recorded — scroll inside the panel to see all entries.
Use IFU
NL-MF-000002704CE 737648W0105040311HSV - NA REAGENTSW0105040502ENTEROVIRUS - NA REAGENTSW0105040521PARECHOVIRUS - NA REAGENTSW0105040704MEASLES - NA REAGENTSW0105040804MUMPS / PAROTITIS - NA REAGENTSPrimary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Mar 29, 2016 | 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.
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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.