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EUDAMED last updated this device on Feb 17, 2026
B-D029AF001B13A34WE>O is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by E-SWIN SAS. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-D029AF001B13A34D029AF001B13AD-D029AF001B13A34
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z129005GENERIC PHOTOSTIMULATORS1 warning recorded — scroll inside the panel to see all entries.
• Pregnant women • On black skin (phototype VI and superior) • Skin recovering from sunburn within the previous month • Previous history of sun allergy • Skin exposed to high pressure artificial UV fewer than 10 days before • Use of tanning products (cream or dietary supplements) on the area to be treated within the previous 2 weeks • Use of tan activators • Injured, burnt, or infected skin • Unusual skin lesions (medical advice should be sought) • People suffering from a skin condition (eczema, inflammation, acne, etc) • Eyelids with permanent make-up • People undergoing a photosensitizing treatment (depending on medical advice, these patients may not be accepted for treatment with WE>O) • Previous history of skin disease • People with diabetes, hemophilia, epilepsy, porphyria cutanea trade • People fitted with a cardiac pacemaker or defibrillator
FR-MF-000011807HD601269280001Primary placement in Austria; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Germany | — | Still on market |
| France | — | Still on market |
| Luxembourg | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Slovenia | — | Still on market |
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.
Certificate health across this manufacturer's portfolio.
28620240995IssuedHZ 1024982-1CancelledNotified 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 →Notified 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 →