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EUDAMED last updated this device on Mar 25, 2026
695593130023040001J7Automatic Hybridization System 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.
06955931302430230401(01)06955931302430
European Medical Device Nomenclature — the EU product classification assigned to this device.
W02050101NUCLEIC ACID HYBRIDIZATION UNITS4 warnings recorded — scroll inside the panel to see all entries.
Read the instructions for use before use.
Do not put inflammable and heat-sensitive materials close to the instrument.
Always wear gloves when operating this instrument.
Avoiding hand scald when working at a temperature above 60℃.
CN-MF-000013666The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | 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 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.B-06955931302881On the marketAlpha Thalassemia Genotyping Kit (gap-PCR)B-06955931304878On the marketAutomatic Integrated Nucleic Acid Analyzer695593130023090804MCOn the marketAutomatic Nucleic Acid Extraction System695593130023050001JJOn the marketAutomatic Nucleic Acid Sample Processing System695593130023101623JPOn the marketNo certificate specifically references this device's Basic UDI-DI.