- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 15, 2026
B-04713945681901EASYMAX® Glucose Control Solution is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by EPS Bio Technology Corp.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
TW-MF-000028384C-02-1095-795-22(01)04713945681901
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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.
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.
Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04713945681901Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-04713945681901681.90UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W010106010801BLOOD TEST STRIPS CONTROLSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →471394568TP1NKOn the marketEASYMAX® Blood Glucose Test Strip[EN]B-04713945681741On the marketEASYMAX® Glucose Control SolutionB-04713945681925On the marketEASYMAX® Glucose Control SolutionB-04713945681918On the marketEASYMAX® Tag Self Monitoring Blood Glucose SystemB-04713945681734On the marketEASYMAX® Tag Self Monitoring Blood Glucose SystemB-04713945681710On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
V76 122705 0006IssuedV13 122705 0003IssuedNotified 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 →