- Role
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- Date of registration
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EUDAMED last updated this device on Mar 29, 2024
081003229PDXA439022SSProciseDx Analyzer is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by ProciseDx Inc.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
US-MF-000040747(01)08100322943909
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
6 warnings recorded — scroll inside the panel to see all entries.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded international RF sources), as these can interfere with the proper operation.
To reduce the risk of UV exposure, do not attempt to open the enclosure and do not open the lid when a test is in process
Complete instrument cleaning as described in the Cleaning section.
The instrument is not designed to withstand moisture, extreme humidity or extreme temperatures.
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 France; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Jul 1, 2020 | Mar 28, 2024 |
| Czechia | Sep 1, 2021 | Mar 28, 2024 |
| Denmark | Apr 1, 2021 | Mar 28, 2024 |
| Spain | Oct 1, 2021 | Mar 28, 2024 |
| Croatia | Mar 1, 2021 | Mar 28, 2024 |
| Italy | Jul 1, 2020 | Mar 28, 2024 |
| Norway | Apr 1, 2021 | Mar 28, 2024 |
| Portugal | Oct 1, 2021 | Mar 28, 2024 |
| Sweden | Sep 1, 2021 | Mar 28, 2024 |
| Slovakia | Sep 1, 2021 | Mar 28, 2024 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08100322943909Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
081003229PDXA439022SS4390UDI 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.
W0201069099VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - 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 →No certificate specifically references this device's Basic UDI-DI.
No 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.