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EUDAMED last updated this device on May 30, 2026
B-06950334821823Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →C-Reactive Protein (CRP) Test Kit (Immunofluorescence) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Genrui Biotech Inc.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →06950334821823Basic 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 →B-0695033482182352026277UDI 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 →(01)06950334821823
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160601C-REACTIVE PROTEIN - RT & POC1 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.
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market | |
| Poland | Still on market |
CN-MF-000017351No 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-06950334802334On the market25-OH Vitamin D (25-OH Vit-D) Quality ControlB-06950334815044On the market25-OH Vitamin D (25-OH Vit-D) Test Kit (Immunofluorescence)B-06950334821991On the marketAlpha Fetoprotein (AFP) Test Kit (Immunofluorescence)B-06950334813798On the marketAnti-streptolysin O (ASO) Detection Kit (Nephelometry)B-06950334819646On the market