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EUDAMED last updated this device on Apr 28, 2026
B-06975984067711Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Hypersensitivity C-reactive Protein (hs-CRP) Assay Kits (Lateral Flow Immunoassay) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Shenzhen Lifotronic Technology Co., Ltd.. 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 →06975984067711Basic 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-069759840677110320303601UDI 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)06975984067711
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01021109C-REACTIVE PROTEIN1 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 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market |
CN-MF-000005654No 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-06975984063607On the marketHyaluronic Acid (eCLIA)B-06975984063621On the marketHyaluronic Acid (eCLIA)B-06975984063614On the marketHypersensitivity C-reactive Protein (hs-CRP) Assay Kits (Lateral Flow Immunoassay)B-06978139075760On the marketHypersensitivity C-reactive Protein (hs-CRP) Assay Kits (Lateral Flow Immunoassay)B-06975984067728On the marketHypersensitivity C-reactive Protein (hs-CRP) Assay Kits (Lateral Flow Immunoassay)B-06975984067735On the market