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KR-MF-000022275CE 572834Allplex™ Respiratory Panel 4 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by Seegene, Inc.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 13, 2026
B-08809240100820Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08809240100820
1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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 32 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Bulgaria | Still on market | |
| Cyprus | Still on market | |
| Czechia | Still on market | |
| Denmark | Still on market | |
| Estonia | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| Finland | Still on market | |
| France | Still on market | |
| Croatia | Still on market | |
| Hungary | Still on market | |
| Ireland | Still on market | |
| Iceland | Still on market | |
| Italy | Still on market | |
| Liechtenstein | Still on market | |
| Lithuania | Still on market | |
| Luxembourg | Still on market | |
| Latvia | Still on market | |
| Malta | Still on market | |
| Netherlands | Still on market | |
| Norway | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Romania | Still on market | |
| Sweden | Still on market | |
| Slovenia | Still on market | |
| Slovakia | Still on market | |
| Türkiye | Still on market | |
| XI | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08809240100820Basic 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-08809240100820RP9803YUDI 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.
W0105070503RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTSNo 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.B-08809240100806On the marketAllplex™ Respiratory Panel 4B-08809240100837On the marketAllplex™ Respiratory Panel 4B-08809240101827On the marketAllplex™ RV Master Assay924010RV10307PCOn the marketAllplex™ RV Master AssayB-08809240101582On the marketAllplex™ RV Master Assay924010RV10307PCOn the marketNo certificate specifically references this device's Basic UDI-DI.