- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 11, 2026
697454156007L7ZK1000 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 Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974541565066697454156007L7ZK1000(01)06974541565066
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.
W01019099CLINICAL CHEMISTRY REAGENTS - OTHERNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Still on market |
CN-MF-000007517No 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.