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EUDAMED last updated this device on Aug 31, 2023
6973262863020104*******AXZ3 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Zybio Inc.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
069732628614023020104(01)06973262861402
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0202010201AUTOMATED 3 PART HEMATOLOGY ANALYSERSPrimary placement in Türkiye; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Aug 31, 2023 | Aug 23, 2028 |
CN-MF-000003349The 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 →No certificate specifically references this device's Basic UDI-DI.
697326286000792GOn the marketQuantitative Real-time PCR System697326286000792GOn the marketQuantitative Real-time PCR System697326286000792GOn the marketZ3 CRP6973262863020101*******96On the marketZybio69732628600120ZHOn the market040051569732628600063ZWOn the marketNo 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.