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EUDAMED last updated this device on Apr 10, 2026
B-06978198482288Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Pepsinogen I/Pepsinogen II(PGⅠ/PGⅡ)Test Kit(Immunofluorescence) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.. 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 →06978198482288Basic 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-069781984822882228UDI 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 →(01)06978198482288
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102069006PEPSINOGEN1 warning recorded — scroll inside the panel to see all entries.
CW018Sterile
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 |
CN-MF-000046524No 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-06978198482196On the marketMyoglobin (Myo) Test Kit (Immunofluorescence)B-06978198482233On the marketN-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Test Kit (Immunofluorescence)B-06978198482110On the marketProcalcitonin (PCT) Test Kit (Immunofluorescence)B-06978198482158On the marketProgesterone (Prog) Test Kit (Immunofluorescence)B-06978198482219On the marketProlactin（PRL） Test Kit (Immunofluorescence)B-06978198482271On the market