- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jan 22, 2026
B-7F07E7IGFBP-3 assay (CLIA) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Xiamen Boson Biotech Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-7F07E77F07V1-B-EU, 7F07U1-B-EU, 7F07P1-B-EUD-7F07E7
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102060406INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 31 warning recorded — scroll inside the panel to see all entries.
CN-MF-000001096Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
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.
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 →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 →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 →Certificate health across this manufacturer's portfolio.
V76 061317 0013IssuedNotified 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.
B-7J14EQOn the marketHypersensitive Troponin T assay (CLIA)B-7J15ESOn the marketIGF-1 assay (CLIA)B-7F08VPGOn the marketImmunoglobulin E assay (CLIA)B-7M08FCOn the marketInfluenza A + B Antigen Test (FIA)B-5N18C529On the marketInsulin assay (CLIA)B-7F01DTOn the marketNo certificate specifically references this device's Basic UDI-DI.