- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 10, 2026
B-06941377300307Antithrombin Ⅲ 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.
06941377300307NX-0016-01(01)06941377300307
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 | Apr 10, 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.
No certificate specifically references this device's Basic UDI-DI.
B-06941377305012On the marketAnti-Xa Testing Kit(Chromogenic Assay)B-06941377306545On the marketAnti-Xa Testing Kit(Chromogenic Assay)B-06941377305043On the marketAntithrombin Ⅲ CalibratorB-06941377300314On the marketAntithrombin III ControlB-06976117454699On the marketAntithrombin III ControlB-06941377305937On the market