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EUDAMED last updated this device on Apr 15, 2025
B-04260107624356smartLAB® pro Blood Glucose Test Strip is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by EPS Bio Technology Corp.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04260107624356D11415(01)04260107624356
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101060101GLUCOSE TEST STRIPS3 warnings recorded — scroll inside the panel to see all entries.
CW007CW010CW032TW-MF-000028384C-02-1095-795-22Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; 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.
No 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.B-04260107620235On the marketsmartLAB® Glucose Control SolutionB-04260107624653On the marketsmartLAB® Glucose Control SolutionB-04260107624608On the marketSOMA® be Blood Glucose MeterB-04260325295147On the marketSOMA® be Blood Glucose MeterB-04260325295130On the marketSOMA® be Self Monitoring Blood Glucose SystemB-04260325290036On the market