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EUDAMED last updated this device on May 21, 2026
B-069733157307472019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based） 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 Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06973315730747C6603CCN-MF-000031032(01)06973315730747
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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 | May 26, 2022 | May 26, 2027 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090502CORONAVIRUS ANTIBODY (AB) - RT & POCPrimary 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 →No certificate specifically references this device's Basic UDI-DI.
B-06979469761545On the market2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection KitB-06973315739771On the market2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection KitB-06973315737975On the market25-Hydroxyvitamin D (25-OH-VD) Test KitB-06979469761262On the marketCertificate 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 →