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- Date of registration
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EUDAMED last updated this device on May 7, 2026
B-06976374750312β2-microglobulin (β2-MG) Test Kit (Fluorescence immunochromatography method) 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.
CN-MF-000045945(01)06976374750312
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 Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary 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.
06976374750312Basic 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-0697637475031225 tests / kit（DR012-4）UDI 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.
W0102160199SPECIFIC PROTEINS RT & POC - OTHERPrimary 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 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-06976374752538On the marketβ-Human Chorionic Gonadotropin (β-HCG) Test Kit (Colloidal Gold)B-06976374752613On the marketβ2-microglobulin (β2-MG) Test Kit (Fluorescence immunochromatography method)B-06976374750305On the marketβ2-microglobulin (β2-MG) Test Kit (Fluorescence immunochromatography method)B-06976374750329On the marketNo certificate specifically references this device's Basic UDI-DI.