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EUDAMED last updated this device on Jul 13, 2026
B-06976232252170Acmex 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.
06976232252170CA03-112-322P15(01)06976232252170
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 detecfon of nasopharyngeal swab and nasal swab specimens.· This testis only for the detection ofproteins from SARS-CoV-2,Influenza A/B,RSVand AV,andRHV,not for any other viruses or pathogens. ·Do not reuse. ·Do not use if the pouch seal orits packaging is compromised. ·Do not use after the expirafion date shown on the pouch. ·Do not mix and interchange different specimens. ·The swabs in the kis are specifcally for use with the COVID-19&Influenza&RSV&AV&RHV Test. Do not use other swabs ·If the test is stbred refngerated,ensure that the test uris are brought to room temper ature(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 must follow this package insert. ·Wear personal protective equipment such as laboratory coats,disposable gloves and eye protection when running each test and handling patient specimens. ·Wash hands thoroughly after firishing the tests ·Do noteat,drink,or smoke in the area where the specimens or kits are being handled. ·Clean up spils thoroughly with appropriate disinfectants. ·Handle allspecimens as if they contain infectious agents.Obserwe established precautions against microbiological hazards throughout testing procedures. ·Dispose of all specimens and used devices in a proper biohazard container.The handling and disposal of the hazardous materials shoukd folow local,nafional,or regionalregulafions. ·Keep out of children's reach. ·f the extraction buffer contacs 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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