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EUDAMED last updated this device on Feb 10, 2022
761333602187AWc8100 Sysmex Tray OBS mod kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Hitachi High-Tech Corporation. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0761333614692708137633001(01)07613336146927
European Medical Device Nomenclature — the EU product classification assigned to this device.
W02069080VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES1 warning recorded — scroll inside the panel to see all entries.
JP-MF-000016991The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; 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 →761333602187AWOn the marketc8100 HHT/Sysmex TrayLane Arm cover761333602188AYOn the marketc8100 MSC modification kit761333602960BJOn the marketCCM Address Extension Unit761333603379BGOn the marketCCM Backend Connection Unit761333603380AZOn the marketCCM Bidirectional Unit761333603372B2On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
MDR 840787IssuedNotified 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.
View in glossary →