- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Mar 27, 2026
B-06941377305913Antithrombin III Testing Kit (Chromogenic Substrate Method) 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.
CN-MF-000024842(01)06941377305913
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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.
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.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06941377305913Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-06941377305913NX-0007-05UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103020602ANTITHROMBINPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
B-06976117454712On the marketAntithrombin III Testing Kit (Chromogenic Substrate Method)B-06941377305906On the marketAntithrombin III Testing Kit (Chromogenic Substrate Method)B-06976117454477On the marketAntithrombin III Testing Kit (Chromogenic Substrate Method)B-06976117454439On the marketAntithrombin III Testing Kit (Chromogenic Substrate Method)B-06976117454422On the marketAntithrombin III Testing Kit (Chromogenic Substrate Method)B-06976117454484On the marketCertificate 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.
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