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EUDAMED last updated this device on May 22, 2026
B-06977981880126Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Osteocalcin/Total Procollagen Type I N-terminal Propeptide/β-CrossLaps Test Kit (QDs-FICA) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Chongqing Juce Life Health Technology Co., Ltd.. Placed on the EU market in Türkiye. 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 →06977981880126Basic 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-06977981880126CL0801UDI 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)06977981880126
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102060699MULTIPLE INDIVIDUAL HORMONES - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW011Sterile
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 Türkiye; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Still on market |
CN-MF-000053774No 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-06977981880324On the marketBlood Glucose/Blood Ketone/Uric Acid/Blood Lipids Test Kit (Electrochemical and Dry Chemistry Methods)B-06977981880164On the marketCardiac Troponin I/Creatine Kinase-MB/Myoglobin Test Kit (QDs-FICA)B-06977981880157On the marketD-Dimer/FDP Test Kit (QDs-FICA)B-06977981880003On the marketFully Automatic Multi-functional Analyzer697798188025YOn the market