- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Mar 3, 2025
590649294ODBKLEOdczynnik do oznaczania hemoglobiny 100ml is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by KOLASA SPÓŁKA JAWNA. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
059064929404572008.5(01)05906492940457
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103010201HAEMOGLOBIN DETERMINATIONS (TOTAL HB)1 warning recorded — scroll inside the panel to see all entries.
CW010PL-MF-000044993The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
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.
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.590649294ODBAKSOn the marketOdbarwiacz Ebnera (do barwienia metodą Ziehl-Neelsena) 250ml590649294ODBAKSOn the marketOdbarwiacz Ebnera (do barwienia metodą Ziehl-Neelsena) 500ml590649294ODBAKSOn the marketOdczynnik do oznaczania hemoglobiny 1L590649294ODBKLEOn the marketOdczynnik do oznaczania hemoglobiny 500ml590649294ODBKLEOn the marketOdczynnik Ehrlicha 100ml590649294ODAOLKOn the market