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EUDAMED last updated this device on May 9, 2026
697454156004KZST8001-1 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by BioTeke Corporation（Wuxi）Co., Ltd. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974541564885ST8001-1(01)06974541564885
European Medical Device Nomenclature — the EU product classification assigned to this device.
W05019099SAMPLES COLLECTION DEVICES - OTHERPrimary placement in Finland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | May 1, 2026 | Dec 31, 2029 |
CN-MF-000007517The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 →Certificate health across this manufacturer's portfolio.
EU-TDA-FI-43117-800031-2025IssuedEU-QMS-FI-40845-800031-2025IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →No certificate specifically references this device's Basic UDI-DI.