- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 9, 2026
B-06974566303407Flu A&B/ Covid-19/ RSV/ Adenovirus /MP Antigen Rapid Test Panel is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhuhai Encode Medical Engineering Co., Ltd.. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CN-MF-000019361(01)06974566303407
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 Finland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | May 26, 2022 | Dec 30, 2027 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06974566303407Basic 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-06974566303407MRP-852UDI 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.
W0105040604INFLUENZA & PARA INFLUENZAPrimary 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.
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.