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CN-MF-000018785H.Pylori Antibody Test Kit is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 18, 2026
B-06952062773245Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06952062773245
3 warnings recorded — scroll inside the panel to see all entries.
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 Germany; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Dec 31, 2024 | Still on market |
| Austria | Dec 31, 2024 | Still on market |
| Belgium | Dec 31, 2024 | Still on market |
| Bulgaria | Dec 31, 2024 | Still on market |
| Cyprus | Dec 31, 2024 | Still on market |
| Czechia | Dec 31, 2024 | Still on market |
| Denmark | Dec 31, 2024 | Still on market |
| Estonia | Dec 31, 2024 | Still on market |
| EL | Dec 31, 2024 | Still on market |
| Spain | Dec 31, 2024 | Still on market |
| Finland | Dec 31, 2024 | Still on market |
| France | Dec 31, 2024 | Still on market |
| Croatia | Dec 31, 2024 | Still on market |
| Hungary | Dec 31, 2024 | Still on market |
| Ireland | Dec 31, 2024 | Still on market |
| Iceland | Dec 31, 2024 | Still on market |
| Italy | Dec 31, 2024 | Still on market |
| Liechtenstein | Dec 31, 2024 | Still on market |
| Lithuania | Dec 31, 2024 | Still on market |
| Luxembourg | Dec 31, 2024 | Still on market |
| Latvia | Dec 31, 2024 | Still on market |
| Malta | Dec 31, 2024 | Still on market |
| Netherlands | Dec 31, 2024 | Still on market |
| Norway | Dec 31, 2024 | Still on market |
| Poland | Dec 31, 2024 | Still on market |
| Portugal | Dec 31, 2024 | Still on market |
| Romania | Dec 31, 2024 | Still on market |
| Sweden | Dec 31, 2024 | Still on market |
| Slovenia | Dec 31, 2024 | Still on market |
| Slovakia | Dec 31, 2024 | Still on market |
| Türkiye | Dec 31, 2024 | Still on market |
| XI | Dec 31, 2024 | 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.
06952062773245Basic 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-06952062773245HPAb1W-5UDI 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.
W0105010402H. PYLORI ANTIBODY ASSAYSCertificate health across this manufacturer's portfolio.
EU-TDA-FI-20642-800030-2025-1SupplementedEU-QMS-FI-44290-800030-2025-1IssuedNotified 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 →Notified 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 →B-06952062771692On the marketH.Pylori Antibody Test KitB-06952062773238On the marketH.Pylori Antibody Test KitB-06952062773283On the marketH.Pylori Antibody Test KitB-06952062700067On the marketH.Pylori Antibody Test KitB-06952062773269On the marketH.Pylori Antibody Test KitB-06952062773276On the marketNo certificate specifically references this device's Basic UDI-DI.