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EUDAMED last updated this device on Jul 13, 2026
B-06976232252194Acmex is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Acmex Bio-Technology (Chongqing) Co., Ltd.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06976232252194CA03-88-422P20(01)06976232252194
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090699OTHER MULTIPLE PATHOGENS - RT & POC1 warning recorded — scroll inside the panel to see all entries.
For in vitro diagnostic use only. The test is designed only for the detection of nasopharyngeal swab and nasal swab specimens.This test is only for the detection of proteins from SARS-CoV-2,Influenza A/B,RSV and AV,not for any other viruses or pathogens. Do not reuse. Do not use if the pouch seal or its packaging is compromised. Do not use after the expiration date shown on the pouch. Do not mix and interchange different specimens. The swabs in the kits are specifically for use with the COVID-19&Influenza &RSV &AV Test.Do not use other swabs. If the test is stored refrigerated,ensure that the test units are brought to room temperature(15-30℃)at least 30 mins before performing testing. Perform the test within 1 hour after the reagent or the pouch of test device is opened. In order to obtain accurate results,the test mustfollow this package insert. Wear personal protective equipment such as laboratory coats,disposable gloves and eyeprotection when running each test and handling patient specimens. Wash hands thoroughly after finishing the tests. Do not eat,drink,or smoke in the area where the specimens or kits are beinghandled.Clean up spills thoroughly with appropriate disinfectants. Handle all specimens as if they contain infectious agents.Observe established precautionsagainst microbiological hazards throughout testing procedures. Dispose of all specimens and used devices in a proper biohazard container.The handling anddisposal of the hazardous materials should follow local,national,or regionalregulations. Keep out of children's reach. If the extraction buffer contacts the skin or eye,flush with copious amounts of water.
CN-MF-000037745Primary placement in Türkiye; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Dec 1, 2026 | Still on market |
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.
View in glossary →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.
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 →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.
Certificate health across this manufacturer's portfolio.
HX 2534915-1IssuedNotified 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.
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