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EUDAMED last updated this device on Jul 13, 2026
B-06976232252033Acmex 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.
06976232252033CA02-11-322P25(01)06976232252033
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090102H. PYLORI - RT & POC1 warning recorded — scroll inside the panel to see all entries.
For professional in vitro diagnostic use only. Do not use after the expiration date shown on the pouch.Do not reuse. Do not use if the pouch seal or its packaging is compromised. Do not mix and interchange different specimens. Wear protective clothing such as laboratory coats,disposable gloves and eye protection whilehandling potentially infectious materials and performing the assay. Wash hands thoroughly after finishing the tests. Do not eat,drink or smoke in the area where the specimens or kits are handled. 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 bio-hazard container.The handlingand disposal of the hazardous materials should follow local,national or regional regulations.Keep out of children's reach.
CN-MF-000037745Primary placement in Türkiye; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Oct 1, 2025 | 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.
View in glossary →