- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 18, 2026
B-GLU-OX601GJGlucose Reagent Kit is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Hangzhou Aichek Medical Technology Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-GLU-OX601GJGLU-OX6011Y,GLU-OX6012Y,GLU-OX6013Y,GLU-OX6014Y,GLU-OX6015Y,GLU-OX6011N,GLU-OX6012N,GLU-OX6013N,GLU-OX6014N,GLU-OX6015NCN-MF-000028093No 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.D-GLU-OX601GJ
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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 Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01010213GLUCOSEPrimary 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-GDF-15706-AEQUOn the marketGH Growth hormone (CLIA)B-GH706-AEZ5On the marketGHB One Step Gamma-hydroxybutyrate TestB-GHB-A01a6XOn the marketGlucose Reagent KitB-GLU-HK601BAOn the marketGlycohemoglobin A1c Reagent KitB-HbA1c601Q8On the marketGlycohemoglobin A1c Reagent KitB-HbA1c-S601EZOn the market