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EUDAMED last updated this device on Mar 31, 2026
695593130025050001KLSample Pretreatment Kit for DNA Methylation Test is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Yaneng BIOscience (Shenzhen) Co., Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06955931303109250501CN-MF-000013666(01)06955931303109
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
CW018Sterile
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 Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105900103SUPPLEMENTAL NA REAGENTSPrimary 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 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.695593130025060001KXOn the marketRespiratory Pathogens Combo Testing KitB-06955931305066On the marketSample Pretreatment Kit for DNA Methylation Test695593130025050001KLOn the marketSpinal Muscular Atrophy Genetic Testing Kit (PCR-Fluorescence Probing)B-06955931303031On the marketSpinal Muscular Atrophy Genetic Testing Kit（PCR-Fluorescence Probing）B-06955931303024On the marketThalassemia Genotyping Kit (PCR-Reverse Dot Blot)B-06955931304960On the marketNo certificate specifically references this device's Basic UDI-DI.