- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 4, 2026
843660129LH8102XLEPASEDIODE LASER AE 2XL HANDPIECE: 5000W-30x12MM-810NM 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.
ES-MF-000019177(01)08436601290601
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
OTHER
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 8 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | May 4, 2026 | Still on market |
| Austria | May 4, 2026 | Still on market |
| Belgium | May 4, 2026 | Still on market |
| Czechia | May 29, 2026 | Still on market |
| Germany | May 4, 2026 | Still on market |
| Ireland | May 4, 2026 | Still on market |
| Luxembourg | May 4, 2026 | Still on market |
| Portugal | May 4, 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.
08436601290601Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
843660129LH8102XLEPASEA445AEUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z120615THERAPEUTIC LASERSPrimary 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.
843660129CHROMIXQTOn the marketCRIOCUUM AESTHETIC843660129CRIOTSJ9On the marketDIODE LASER AE L HANDPIECE: 2000W-10x9MM-755NM843660129LH755LEPATLOn the marketDIODE LASER AE L HANDPIECE: 2000W-10x9MM-810NM843660129LH810LEPAQSOn the marketDIODE LASER AE L HANDPIECE: 4000W-10x9MM-1060NM843660129LH1060LEPAXNOn the marketCertificate 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 →