- Role
- Country
- Date of registration
- Address
FR-MF-000020946G1 0 15735 0024 PREMIO 32 EVO laser A-G program is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Sedatelec. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jan 19, 2026
B-03760262493138Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03760262493138
1 warning recorded — scroll inside the panel to see all entries.
• Direct contact with mucosal membranes (only for PREMIO 30 EVO and 32 EVO) or broken skin. • Treatment of endocrine areas (particularly in children). • Treatment of the globe of the eye. • Treatment of abdomen in pregnant women. • Treatment of the chest region in a patient with a cardiac pacemaker. • Previous use of anticoagulants and aspirin. • Past history of cheloid or hypertrophic scarring. • Active infection/compromised immune system. • Past history of herpes And more specifically, for people with a history of photo sensitivity: • Exposure to sunlight or artificial UV light for 3 to 4 weeks before treatment. • Hypersensitivity to light at 905 nm. • Receipt of medicines when exposure to sunlight is contraindicated • Receipt of oral isotretinoin medicines or anticoagulants
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 France; available across 16 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Cyprus | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Ireland | — | Still on market |
| Italy | — | Still on market |
| Luxembourg | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | 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.
03760262493138Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-03760262493138112049UDI 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 LASERSNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
G15 015735 0033SupplementedNotified 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 →