- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Mar 25, 2026
B-06976117451216Thrombin Time Assay Reagent (Coagulation 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)06976117451216
1 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.
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.
06976117451216Basic 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-06976117451216NX-0004-01UDI 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.
W0103020103THROMBIN TIME / REPTILASE / BATROXBIN TIMEPrimary 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 →No certificate specifically references this device's Basic UDI-DI.
B-06970493097082On the marketSerum Amyloid A Protein Reagent(Immunonephelometric Method)6970493090506004NXOn the marketSerum Amyloid A Protein Reagent(Immunonephelometric Method)B-06970493092872On the marketThrombin Time Assay Reagent (Coagulation Method)B-06976117451230On the marketThrombin Time Assay Reagent (Coagulation Method)B-06976117451247On the marketThrombin Time Assay Reagent（Coagulation Method）B-06976117451285On the market