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EUDAMED last updated this device on Apr 30, 2026
843660129LASTSMDU9ENEKA PRO AESTHETIC is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Termosalud, S.L.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08436601290564M91AE(01)08436601290564
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z120615THERAPEUTIC LASERS1 warning recorded — scroll inside the panel to see all entries.
CW999ES-MF-000019177The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Spain; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Apr 30, 2026 | Still on market |
| Austria | Apr 30, 2026 | Still on market |
| Belgium | Apr 30, 2026 | Still on market |
| Germany | Apr 30, 2026 | Still on market |
| Ireland | Apr 30, 2026 | Still on market |
| Luxembourg | Apr 30, 2026 | Still on market |
| Portugal | Apr 30, 2026 | Still on market |
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 →843660129LH3WLXLEPAB6On the marketDIODE LASER AE XL HANDPIECE: 4000W-20x9MM-755NM843660129LH755XLEPAJYOn the marketDIODE LASER AE XL HANDPIECE: 4000W-20x9mm-810nm843660129LH810XLEPAFEOn the marketINÜO843660129INUOMQM6On the marketIONIC PADS843660129IOPADEWOn the marketNFUSE843660129NFUSEH7On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
240/MDRSupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →