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EUDAMED last updated this device on May 28, 2026
B-06979469760074Quality Control (CEA) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Nanjing Vazyme Medical Technology Co.,Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06979469760074M3802Q(01)06979469760074
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102152005TUMOUR MARKER CONTROLS3 warnings recorded — scroll inside the panel to see all entries.
CW007CW010CW032CN-MF-000031032Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Still on market |
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.
EU-TDA-FI-66922-800033-2025IssuedNotified 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.
EU-QMS-FI-01219-800033-2025IssuedNotified 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.
No certificate specifically references this device's Basic UDI-DI.
B-06979469760104On the marketQuality Control (Beta Human Chorionic Gonadotropin)B-06979469760111On the marketQuality Control (CEA)B-06979469760067On the marketQuality Control (CRP)B-06973315738880On the marketQuality Control (D-Dimer)B-06973315738910On the marketQuality Control (E2)B-06979469760241On the market