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EUDAMED last updated this device on May 28, 2026
B-06979469760746Carbohydrate Antigen 19-9 (CA19-9) Test Kit 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.
06979469760746M5403CCCN-MF-000031032(01)06979469760746
4 warnings recorded — scroll inside the panel to see all entries.
CW010CW009CW007CW032Sterile
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 Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102030103CANCER ANTIGEN 19-9Primary 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 →B-06979469760739On the marketCarbohydrate Antigen 19-9 (CA19-9) Test KitB-06979469760722On the marketCarbohydrate Antigen 19-9 (CA19-9) Test KitB-06979469760715On the marketCarcinoembryonic Antigen (CEA) Test KitB-06979469761347On the marketCarcinoembryonic Antigen (CEA) Test KitB-06979469761361On the marketCarcinoembryonic Antigen (CEA) Test KitB-06979469761330On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
EU-TDA-FI-66922-800033-2025IssuedEU-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.
View in glossary →Notified 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.
View in glossary →