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EUDAMED last updated this device on Sep 23, 2022
B-06926802604793Functional Fibrinogen Assay is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06926802604793MCT00602E(01)06926802604793
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103020201FIBRINOGEN ASSAYS (FACTOR I)CN-MF-000005925Primary placement in Netherlands; available across 1 country total.
Placed on the market in Netherlands; 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 →Certificate health across this manufacturer's portfolio.
G15 086916 0062Supplemented178/MDRSupplementedV13 086916 0064SupplementedNotified 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 →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 →69268026HameaTX001V7On the marketFully-automated Haemostasis Analyzer69268026HameaTX001V7On the marketFunctional Fibrinogen AssayB-06926802603802On the marketFunctional Fibrinogen AssayB-06926802604809On the marketH-FABP (CLIA)B-06926802604472On the marketH-FABP ControlB-06926802604557On the marketNo certificate specifically references this device's Basic UDI-DI.