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US-MF-000017851Aptiva® APS IgM Controls is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Inova Diagnostics. Inc.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Feb 29, 2024
84307930409143YPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08430793040914
The 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.
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 Italy; available across 20 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Feb 15, 2024 | Still on market |
| Austria | Feb 15, 2024 | Still on market |
| Belgium | Feb 15, 2024 | Still on market |
| Cyprus | Feb 15, 2024 | Still on market |
| Germany | Feb 15, 2024 | Still on market |
| Denmark | Feb 15, 2024 | Still on market |
| Spain | Feb 15, 2024 | Still on market |
| Finland | Feb 15, 2024 | Still on market |
| France | Feb 15, 2024 | Still on market |
| Croatia | Feb 15, 2024 | Still on market |
| Ireland | Feb 15, 2024 | Still on market |
| Liechtenstein | Feb 15, 2024 | Still on market |
| Luxembourg | Feb 15, 2024 | Still on market |
| Latvia | Feb 15, 2024 | Still on market |
| Malta | Feb 15, 2024 | Still on market |
| Netherlands | Feb 15, 2024 | Still on market |
| Poland | Feb 15, 2024 | Still on market |
| Portugal | Feb 15, 2024 | Still on market |
| Slovenia | Feb 15, 2024 | Still on market |
| XI | Feb 15, 2024 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08430793040914Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
84307930409143Y725142UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102152011CONTROLS FOR AUTOIMMUNITYNo 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.84307930407784GOn the marketAptiva® APS IgG Reagent84307930407163SOn the marketAptiva® APS IgM Calibrators843079304090743On the marketAptiva® APS IgM Reagent843079304085345On the marketAptiva® CTD Essential Calibrators843079304018137On the marketAptiva® CTD Essential Controls84307930401983QOn the marketNo certificate specifically references this device's Basic UDI-DI.