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EUDAMED last updated this device on Oct 28, 2024
590518640EM-R1801100AUPATHOSOLUTIONS - ClearFix, 500ml is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Grzegorz Pałkowski Elektro Med. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05905186401991EM-R18011001(01)05905186401991
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)16 warnings recorded — scroll inside the panel to see all entries.
formaldehyde
PL-MF-000023609The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Poland; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | Nov 18, 2024 | Still on market |
| Czechia | Nov 18, 2024 | 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.
590518640EM-300ZFOn the marketPathosolutions - Cardboard Slide Tray for 32 pcs, with lid590518640EM-300ZFOn the marketPATHOSOLUTIONS - ClearFix, 1L590518640EM-R1801100AUOn the marketPATHOSOLUTIONS - ClearFix, 5L590518640EM-R1801100AUOn the marketPathosolutions - Embedding stamp, 12 mm590518640EM-A1400100WTOn the marketPathosolutions - PCP Plus590518640EM-R1802100B3On 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.