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EUDAMED last updated this device on May 13, 2026
B-06971049341611Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →LeECG OS12 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.
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 →06971049341611Basic 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 →B-06971049341611LeECG OS12UDI 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 →(01)06971049341611
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12050301GENERAL PURPOSE ELECTROCARDIOGRAPHSSterile
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 →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Netherlands; available across 15 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Cyprus | Still on market | |
| Czechia | Still on market | |
| Germany | Still on market | |
| Denmark | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| France | Still on market | |
| Ireland | Still on market | |
| Italy | Still on market | |
| Luxembourg | Still on market | |
| Poland | 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)