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EUDAMED last updated this device on Jun 16, 2026
697645797YY01Y4EUYI p16/Ki-67 Dual Staining kit (immunocytochemical method) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Shenzhen YOUYI Bioscience Ltd.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06976457970880100PKI-48CN-MF-000034584(01)06976457970880
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.
CW999Sterile
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 Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Jan 1, 2027 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01030711IMMUNOHISTOLOGY KITSPrimary 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 →B-06976457970972On the marketEUYI p16/Ki-67 Dual Staining kit (immunocytochemical method)B-06976457970965On the marketEUYI p16/Ki-67 Dual Staining kit (immunocytochemical method)697645797YY01Y4On the marketEUYI Pap Staining Kit697645797PSK2WOn the marketEUYI Pap Staining Kit697645797PSK2WOn the marketEUYI α-Thalassemia Genotyping Kit (Nondeletion)B-06976457970033On 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.