- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 21, 2026
B-FDTRO-402bHGHFcTnI Quantitative Test Kit (Time-Resolved FIA) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Healgen Scientific Limited Liability Company. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-FDTRO-402bHGHFFDTRO-402bUS-MF-000018839No 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.D-FDTRO-402bHGHF
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
2 warnings recorded — scroll inside the panel to see all entries.
CW010CW009Sterile
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.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01021306TROPONIN I/TPrimary 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 →No certificate specifically references this device's Basic UDI-DI.
B-FDCS-PN20HG35On the marketCT ControlB-FDCT-PN20HG3QOn the marketcTnI ControlB-FDTRO-PN20HGXHOn the marketcTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)B-FDCAR-T402aHG92On the marketcTnl/ Myo/ CK-MB ControlB-FDCAR-PN20HG5NOn the marketcTnT ControlB-FDTNT-PN20HGXLOn the market