- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 8, 2026
B-06976374752354Quanlity Control For Urine Analyzer is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by BIOBASE POCT CO.,LTD. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06976374752354BQ-A U1: 1 × 8 mL; U2: 1 × 8 mL; U3: 1 × 8 mL（DR088）(01)06976374752354
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101050207URINE CONTROLSCN-MF-000045945Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
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 →B-06976374750787On the marketProlactin (PRL) Test Kit (Fluorescence immunochromatography method)B-06976374750725On the marketQuanlity Control For Urine AnalyzerB-06976374752361On the marketRespiratory syncytial virus Antigen Rapid Test Kit (Colloidal Gold)B-06976374752491On the marketRespiratory syncytial virus Antigen Rapid Test Kit (Colloidal Gold)B-06976374752507On the marketRheumatoid factor (RF)Test Kit（Fluorescence immunochromatography method）B-06976374752163On the marketNo 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.