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EUDAMED last updated this device on May 18, 2026
3760286540235035DPLecstrip is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by ASFALIS. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
03760286540108A1-05R2-11 packaging level registered — each level carries its own UDI-DI.
03760286540108× 1 unitBase unit03760286540115× 40 units(01)03760286540108
European Medical Device Nomenclature — the EU product classification assigned to this device.
C020501ECG ELECTRODES7 warnings recorded — scroll inside the panel to see all entries.
Though the device do not contain magnetizable materials, its use in MRI room is not advisable. Such a use can cause induced currents in the cable (due to their length) that could harm the patient.
OTHER
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The device is disposable and must not be used with several patients
Primary placement in Germany; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Nov 14, 2016 | Still on market |
| Denmark | May 19, 2017 | Still on market |
| Spain | Dec 16, 2016 | Still on market |
| Netherlands | Nov 14, 2016 | Still on market |
FR-MF-000003046The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
check IFU for detailed description of warnings and cautions
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 →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 →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 →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
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.
No 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.