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EUDAMED last updated this device on Apr 3, 2026
B-06955931305165Genetic Deafness Gene Testing Kit (Multicolor Melting Curve Analysis) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. 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.
CN-MF-000013666(01)06955931305165
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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 Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | 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.
06955931305165Basic 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-06955931305165213401UDI 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.
W0106010199MONOGENETIC DISORDERS TESTS - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →B-06955931305202On the marketDNA Methylation Detection Kit for Human SDC2, SEPTIN9 and TFPI2 Gene (Real-Time PCR)B-06955931305219On the marketFully Automated Nucleic Acid Amplification Hybridization Analyzer695593130023080807M7On the marketGenetic Deafness Gene Testing Kit (Multicolor Melting Curve Analysis)B-06955931305172On the marketGroup B Streptococcus Nucleic Acid Detection Kit (Real-Time PCR)B-06955931305226On the marketGroup B Streptococcus Nucleic Acid Detection Kit (Real-Time PCR)B-06955931305233On the marketNo certificate specifically references this device's Basic UDI-DI.
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.