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Sign in to claim this brandMECTRONIC MEDICALE SRL
Italy·IT-MF-000040989
Last updated May 30, 2026
What MECTRONIC MEDICALE SRL makes
Mectronic Medicale Srl manufactures professional medical lasers and diathermy systems for musculoskeletal and physical therapy. Their laser devices include models like the ILUX SMART (20W 810+1064nm) and variations of the iLux LF series, designed for tissue treatment and pain management. The company also produces medium-wave diathermy systems, such as the CHELT F QS 30 and Ixyon XP F50 ED, used for deep tissue heating and therapeutic applications. Additional offerings include the Doctor Tecar system, intended for tissue regeneration and recovery.
The company’s devices are classified under EU regulations as Class II, Class IIa, and Class IIb, indicating moderate to high risk. These products are registered in the EU’s eudamed database and the FDA’s UDI system, reflecting compliance with European and U.S. regulatory requirements. Mectronic Medicale Srl is headquartered in Italy.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Mectronic Medicale Srl manufacture?
Mectronic Medicale Srl specialises in professional medical devices for musculoskeletal and physical therapy. Their portfolio includes professional laser systems (such as the ILUX SMART and iLux LF series) designed for tissue treatment, pain relief, and regenerative therapy, as well as medium-wave diathermy systems (like the CHELT F QS 30 and Ixyon XP F50 ED) used for deep tissue heating and therapeutic applications. These devices target clinical needs in rehabilitation and wound care.
Where is Mectronic Medicale Srl based, and how does that affect its regulatory standing?
Mectronic Medicale Srl is headquartered in Italy, which means its devices must comply with EU Medical Device Regulations (MDR). The company’s products are classified under EU Class II, IIa, and IIb, indicating moderate to high risk levels requiring rigorous pre-market evaluation. This classification aligns with the regulatory framework governing medical devices in the EU, ensuring patient safety and device performance standards.
Which regulatory databases list Mectronic Medicale Srl’s devices?
Mectronic Medicale Srl’s devices are registered in two key global databases: the EU’s eudamed system, which tracks medical devices authorised under EU regulations, and the FDA’s UDI (Unique Device Identification) system in the U.S. These listings confirm compliance with both European and American regulatory requirements, facilitating transparency and traceability for healthcare providers and authorities.
How are Mectronic Medicale Srl’s devices classified under EU and U.S. regulations?
Under EU regulations, Mectronic Medicale Srl’s devices fall into Class II, IIa, and IIb, categorised based on their risk levels—Class IIb representing the highest risk among the three. This classification requires manufacturers to demonstrate clinical safety and performance through technical documentation, clinical evaluations, and conformity assessments before authorisation. While the FDA does not use the same class system, its UDI system ensures device traceability and compliance with U.S. standards, including pre-market approvals where applicable.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Italy
- Address
- 15, Orio al Serio, Grassobbio (BG), Italy
- Website
- mecmedix.com
- —
- —
- [email protected]
- Phone
- +39035656080
- PRRC Contact
- Ennio Aloisini
- EUDAMED SRN
- IT-MF-000040989
- FDA FEI Number
- —
- DUNS Number
- 429098838
Catalogue (45)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ILUX SMART (20W 810+1064nm) | 10LFV20 | EUDAMED | Class IIb | Active |
| ILUX SMART (open model) | 10LF | EUDAMED | Class IIb | Active |
| Chelt F Qs 30 | 1CTFQS30 | FDA UDI | Class II | Active |
| Ixyon XP F50 ED | 1IXF50ED | FDA UDI | Class II | Active |
| iLux LF D20 | 1LFD20 | EUDAMEDFDA UDI | Class II | Active |
| iLux LF D10 | 1LFD10 | EUDAMEDFDA UDI | Class II | Active |
| iLux LF HPS V15 | 1LFHV15 | FDA UDI | Class II | Active |
| iLux LF HPS T30 | 1LFHT30 | FDA UDI | Class II | Active |
| iLux LF V10 | 1LFV10 | EUDAMEDFDA UDI | Class II | Active |
| iLux LF R05 | 1LFR05 | EUDAMEDFDA UDI | Class II | Active |
| iLux LF V15 | 1LFV15 | EUDAMEDFDA UDI | Class II | Active |
| Doctor Tecar | Doctor Tecar | FDA UDI | Class II | Active |
| iLux LF D15 | 1LFD15 | FDA UDI | Class II | Active |
| iLux LF Y15 | 1LFY15 | EUDAMEDFDA UDI | Class II | Active |
| iLux LF HPS D30 | 1LFHD30 | FDA UDI | Class II | Active |
| iLux LF D12 | 1LFD12 | FDA UDI | Class II | Active |
| Ixyon XP F92 OA | 1IXF92OA | FDA UDI | Class II | Active |
| iLux LF HPS D15 | 1LFHD15 | FDA UDI | Class II | Active |
| iLux LF HPS V30 | 1LFHV30 | FDA UDI | Class II | Active |
| iLux LF HPS D20 | 1LFHD20 | FDA UDI | Class II | Active |
| iLux LF HPS V10 | 1LFHV10 | FDA UDI | Class II | Active |
| iLux LF HPS V20 | 1LFHV20 | FDA UDI | Class II | Active |
| Chelt F Qr 30 | 1CTFQR30 | FDA UDI | Class II | Active |
| iLux LF T30 | 1LFT30 | FDA UDI | Class II | Active |
| iLux LF D25 | 1LFD25 | FDA UDI | Class II | Active |
| iLux LF HPS D25 | 1LFHD25 | FDA UDI | Class II | Active |
| iLux LF HPS V25 | 1LFHV25 | FDA UDI | Class II | Active |
| iLux LF HPS R2 | 1LFHR2 | FDA UDI | Class II | Active |
| Ixyon XP F30 | 1IXF30 | FDA UDI | Class II | Active |
| iLux LF HPS T20 | 1LFHT20 | FDA UDI | Class II | Active |
| iLux LF HPS D10 | 1LFHD10 | FDA UDI | Class II | Active |
| iLux LF HPS R05 | 1LFHR05 | FDA UDI | Class II | Active |
| iLux LF R2 | 1LFR2 | EUDAMEDFDA UDI | Class II | Active |
| Chelt F Eb 60 | 1CTFEB60 | FDA UDI | Class II | Active |
| iLux LF HPS Y10 | 1LFHY10 | FDA UDI | Class II | Active |
| iLux LF Y20 | 1LFY20 | EUDAMEDFDA UDI | Class II | Active |
| Ixyon XP F16 | 1IXF16 | FDA UDI | Class II | Active |
| Ixyon Xp Ultra | 10IXUED050X | EUDAMED | Class IIb | Active |
| iLux LF HPS Y15 | 10LFHY15 | EUDAMEDFDA UDI | Class IIb | Active |
| PulsWave Plus | 11MMP.PW.0,2JF10 | EUDAMED | Class IIa | Active |
| Doctor Tecar Plus | 10DTP | EUDAMEDFDA UDI | Class IIb | Active |
| Ixyon Xp | 10IXSTC016X | EUDAMED | Class IIb | Active |
| iLux LF Y10 | 10LFY10 | EUDAMEDFDA UDI | Class IIb | Active |
| Ixyon Xp | 10IXSQA030X | EUDAMED | Class IIb | Active |
| Doctor Tecar Smart | 10DTS | EUDAMEDFDA UDI | Class IIb | Active |
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