- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 28, 2026
69449040AB3000013ZJAuto Hematology Analyzer is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0690305310610869449040AB3000013ZJLT-360S(01)06903053106108
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.
W0202010101AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)1 warning recorded — scroll inside the panel to see all entries.
CW011No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | May 26, 2022 | Still on market |
| Netherlands | May 26, 2022 | Still on market |
CN-MF-000014156No 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.