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EUDAMED last updated this device on Apr 7, 2022
B-07290018152003Sofwave is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Sofwave Medical Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07290018152003FG00001INT(01)07290018152003
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z120610ULTRASOUND THERAPY EQUIPMENT5 warnings recorded — scroll inside the panel to see all entries.
Pregnancy or planning to become pregnant, having given birth less than three months ago, and/or breast feeding.
Contraindications:• Open wounds or lesions on the face and/or neck. • Severe or cystic acne on the face and/or neck • Pacemakers and electronic device implants in the treated area.
Degree of Protection Against Electric Shock
Precautions:• Presence of any active systemic or local infections. • Presence of active local skin disease that may alter wound healing. • History of chronic drug or alcohol abuse. • Significant scarring in the area to be treated. • Presence of a metal stent or implant in the facial area. • The Sofwave device has not been evaluated for use over various materials. • Treatment is not recommended for use directly over areas with a dermal filler. • Taking Isotretinoin or other retinoid within the past six months. • Taking psychiatric drugs, antiplatelet or anticoagulant within the past six months. • As per the physician's discretion, any physical or mental condition which might make it unsafe for the patient to be treated.
IL-MF-0000192003902551CE01Primary placement in Spain; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Dec 31, 2019 | Still on market |
| Germany | Mar 13, 2020 | Still on market |
| France | May 24, 2021 | Still on market |
| Italy | Feb 23, 2022 | Still on market |
| Poland | Jan 21, 2021 | Still on market |
| Türkiye | Sep 29, 2021 | 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 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.This device is not currently linked to any other device.
No certificate specifically references this device's Basic UDI-DI.