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EUDAMED last updated this device on May 24, 2026
B-06971049341260TH3 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Shenzhen Carewell EIectronics Co., Ltd.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06971049341260B-06971049341260TH3(01)06971049341260
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12050403ECG HOLTER RECORDERSNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Netherlands; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Germany | Still on market | |
| Spain | Still on market | |
| France | Still on market | |
| Ireland | Still on market | |
| Italy | Still on market | |
| Luxembourg | Still on market | |
| Portugal | Still on market |
CN-MF-000026800No 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.G1 050440 0033(or GCQ 050440 0034)