- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 10, 2026
B-08809115900890GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by OSANG Healthcare Co., Ltd. Placed on the EU market in Slovakia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
KR-MF-000032605TUV SUD - V1 001395 0018(01)08809115900890
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OTHER
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 Slovakia; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SlovakiaPrimary placement | Jun 3, 2026 | 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.
08809115900890Basic 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-08809115900890INFCL001AUDI 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.
W0201060102BLOOD GLUCOSE METERSPrimary 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-08809115901651On the marketGLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testingB-08800323056140On the marketGLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testingB-08809115907561On the marketGLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testingB-08809115900876On the marketGLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testingB-08809115900395On the marketGLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testingB-08809115907066On 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.