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EUDAMED last updated this device on Jun 5, 2026
B-06976117451414Fibrinogen Calibrator is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Shenzhen Dymind Biotechnology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06976117451414NX-0009-02(01)06976117451414
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103020701CALIBRATION PLASMA FOR HAEMOSTASIS1 warning recorded — scroll inside the panel to see all entries.
CW011CN-MF-000024842Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Mar 20, 2022 | Dec 31, 2099 |
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 →Certificate health across this manufacturer's portfolio.
HX 2183501-1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →B-06976117451162On the marketFibrinogen Assay Kit (Modified Clauss Method)B-06976117451148On the marketFibrinogen Assay Kit (Modified Clauss Method)B-06976117451155On the marketFibrinogen CalibratorB-06976117451407On the marketGlycosylated Hemoglobin Reagent (Fluorescence Immunochromatography)B-06941377300406On the marketGlycosylated Hemoglobin Reagent (Fluorescence Immunochromatography)B-06941377302523On the marketNo certificate specifically references this device's Basic UDI-DI.