- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 15, 2026
697454156014L4BTK-E04-B1-20-00 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 Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974541565301697454156014L4BTK-E04-B1-20-00(01)06974541565301
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.
W0599IVD GENERAL USE CONSUMABLE DEVICES - OTHERNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Austria; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | Still on market | |
| Belgium | Still on market | |
| Bulgaria | Still on market | |
| Cyprus | Still on market | |
| Czechia | Still on market | |
| Germany | Still on market | |
| Denmark | Still on market | |
| Estonia | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| Finland | Still on market | |
| France | Still on market | |
| Croatia | Still on market | |
| Hungary | Still on market | |
| Ireland | Still on market | |
| Iceland | Still on market | |
| Italy | Still on market | |
| Liechtenstein | Still on market | |
| Lithuania | Still on market | |
| Luxembourg | Still on market | |
| Latvia | Still on market | |
| Malta | Still on market | |
| Netherlands | Still on market | |
| Norway | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Romania | Still on market | |
| Sweden | Still on market | |
| Slovenia | Still on market | |
| Slovakia | Still on market | |
| Türkiye | Still on market | |
| XI | Still on market |
CN-MF-000007517Certificate health across this manufacturer's portfolio.
EU-TDA-FI-43117-800031-2025IssuedEU-QMS-FI-40845-800031-2025Issued