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EUDAMED last updated this device on May 21, 2026
B-FAAMH-302aHGLWPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →AMH 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.
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 →D-FAAMH-302aHGLWBasic 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 →B-FAAMH-302aHGLWFAAMH-302aUDI 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 →D-FAAMH-302aHGLW
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102050215ANTI-MÛLLERIAN HORMONE2 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.
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market |
US-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.B-FEAFP-PN20HG78On the marketAFP Quantitative Test Kit (Time-Resolved FIA)B-FEAFP-302aHGQHOn the marketAMH ControlB-FAAMH-PN20HG3MOn the marketAMH Quantitative Test Kit (Time-Resolved FIA)B-FAAMH-402aHGMBOn the marketAnalysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)B-00810173656900On the marketBeta-HCG ControlB-FAHCG-PN20HG27On the market