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EUDAMED last updated this device on May 18, 2026
B-06945934603429HK-D01-XL is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Changzhou Huankang Medical Device Co., Ltd.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06945934603429B-06945934603429HK-D01-XL(01)06945934603429
European Medical Device Nomenclature — the EU product classification assigned to this device.
R03010201AIR/OXYGEN MASKS1 warning recorded — scroll inside the panel to see all entries.
CW009No certificate specifically references this device's Basic UDI-DI.
Primary placement in Romania; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | Still on market |
CN-MF-000009030No 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.DD 60149774 0001326012944