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EUDAMED last updated this device on Mar 28, 2024
353267F00196P97BIOSYNEX Blood Lysis is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by BIOSYNEX. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
035326786072383150077(01)03532678607238
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01019001BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)Primary placement in France; available across 1 country total.
Placed on the market in France; per-country availability dates not published.
FR-MF-000014073The 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 →B-03532678599793On the marketBIOSYNEX Autoteste de ovulaçãoB-03532678592770On the marketBIOSYNEX Bladder Tumor AntigenB-03700531700642On the marketBIOSYNEX C. difficile GDH353267F00076P8NOn the marketBIOSYNEX CryptoPS353267F00074P8GOn the marketBIOSYNEX Early pregnancy test 8 daysB-03532678589312On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
030/MDRIssuedG10 002187 0009IssuedNotified 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 →Notified 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 →