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EUDAMED last updated this device on Jul 19, 2023
B-06950715500507Blood Glucose Meter is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by Cofoe Medical Technology Co.,Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06950715500507KFA110(01)06950715500507
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201060102BLOOD GLUCOSE METERS1 warning recorded — scroll inside the panel to see all entries.
This blood glucose meter cannot be used for diabetes diagnosis or for blood glucose monitoring of newborns
CN-MF-000001077V1 101949 0003Primary placement in Spain; available across 1 country total.
Placed on the market in Spain; 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.
B-69507155KFA06CHPOn the marketBlood Glucose MeterB-06950715500545On the marketBlood Glucose MeterB-06950715500477On the marketblood glucose monitoring system69507155CKIT3PFOn the marketblood glucose monitoring system69507155CKIT5PKOn the marketblood glucose monitoring system69507155KKIT4S9On the marketCertificate health across this manufacturer's portfolio.
V76 114578 0006IssuedV13 114578 0005IssuedV76 114578 0007IssuedNotified 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 →