- Role
- Country
- Date of registration
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CN-MF-000025964Human Epididymis Protein 4（HE4）Detection Kit（Magnetic Solid Phase Chemiluminescent） is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Biobase Diagnostic Technology (Shandong) Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 11, 2026
B-06974969981387Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06974969981387
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.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06974969981387Basic 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-0697496998138750 Tests/kit（DR1098-1）UDI 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.
W0102030119HUMAN EPIDIDYMIS PROTEIN 4No certificate specifically references this device's Basic UDI-DI.
No 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-06974969982186On the marketHuman Epididymis Protein 4（HE4）Detection Kit（Magnetic Solid Phase Chemiluminescent）B-06974969982520On the marketHuman Epididymis Protein 4（HE4）Detection Kit（Magnetic Solid Phase Chemiluminescent）B-06974969981950On the marketHuman Growth Hormone（GH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)B-06974969982568On the marketHuman Growth Hormone（GH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)B-06974969981424On the marketHuman Growth Hormone（GH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)B-06974969981998On the market