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EUDAMED last updated this device on Jun 5, 2024
88061413UR6400HCDUS R-60S is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by DFI Co.,Ltd.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
088061413036195A60(01)08806141303619
European Medical Device Nomenclature — the EU product classification assigned to this device.
W02010701URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTSPrimary placement in Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
KR-MF-000015786The 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.
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 →Certificate health across this manufacturer's portfolio.
HX 2028254-1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
88061413UR6200H2On the marketDUS R-50S88061413UR6300H7On the marketDUS R-600S88061413UR6100GVOn the marketHEALTHMATE Vaginal pHB-KR-MF-000015786PROHMTWOn the marketQUCARE Self Blood Uric Acid Test StripB-KR-MF-000015786VUADXOn the marketQUCARE® Lipid test stripB-KR-MF-000015786LIPIDQ9On the marketNo certificate specifically references this device's Basic UDI-DI.