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EUDAMED last updated this device on May 12, 2026
B-06974566302356Gonorrhea + Chlamydia Antigen Combo Test Cassette is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by Zhuhai Encode Medical Engineering Co., Ltd.. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974566302356SGC-52220CN-MF-000019361No.V1 106272 0002No 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.(01)06974566302356
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 Austria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | May 26, 2022 | Dec 30, 2027 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090199BACTERIOLOGY - RT & POC - OTHERPrimary 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-06974566302370On the marketGonorrhea + Chlamydia Antigen Combo Test CassetteB-06974566302349On the marketGonorrhea + Chlamydia Antigen Combo Test CassetteB-06974566302332On the marketGonorrhea + Chlamydia Antigen Combo Test CassetteB-06974566302363On the marketGonorrhea + Chlamydia Antigen Combo Test CassetteB-06974566302325On the marketGonorrhea + Chlamydia Antigen Combo Test CassetteB-06974566302318On the marketNo certificate specifically references this device's Basic UDI-DI.