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EUDAMED last updated this device on May 30, 2026
697448899CY-98/0/4/2/8V38Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Saliva Collection Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Huachenyang (Shenzhen) Technology Co., Ltd.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →06974488992321Basic 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 →697448899CY-98/0/4/2/8V38CY-98000AUDI 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 →(01)06974488992321
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104010203TRANSPORT MEDIA1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in France; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Still on market | |
| Spain | Still on market |
CN-MF-000020236No 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.697448899CY-A1/3/8/2/8V73On the marketAutomatic Nucleic Acid Extraction System697448899CY-A1/3/8/2/8V73On the marketAutomatic Nucleic Acid Extraction System697448899CY-A1/3/8/2/8V73On the marketCell-Free DNA Blood Collection Tube697448899CY-F0/0/5/2/6V7TOn the marketCell-Free DNA Blood Collection Tube697448899CY-F0/0/5/2/6V7TOn the market