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- Date of registration
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TW-MF-000028384C-02-1095-795-22EASYMAX® Blood Glucose Test Strip[EN] 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.
EUDAMED last updated this device on Jun 1, 2026
B-04713945681741Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04713945681741
4 warnings recorded — scroll inside the panel to see all entries.
CW007CW010CW009CW032Sterile
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.
04713945681741Basic 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-04713945681741681.74UDI 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.
W0101060101GLUCOSE TEST STRIPSNo certificate specifically references this device's Basic UDI-DI.
B-04713945681840On the marketEASYMAX® Blood Glucose Test StripB-04713945681871On the marketEASYMAX® Blood Glucose Test StripB-04713945681864On the marketEASYMAX® Glucose Control SolutionB-04713945681925On the marketEASYMAX® Glucose Control SolutionB-04713945681901On the marketEASYMAX® Glucose Control SolutionB-04713945681918On the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.