Manufacturer

Termosalud

SpainLegal entities : Termosalud, S.L.

Markets : Germany · Spain · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 8 · class I, II · latest in 2026 · see on the FDA website

regulatory@termosalud.com

5 categories, 59 models including 58 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Dermal regeneration equipment	Z12040203	CAP DEEP ACTION CAP DEEP ACTION FOCUS CAP ELECTRODE CONICAL SEA/SP CAP ELECTRODE CURVED 13MM SEA/SP CAP ELECTRODE CURVED 23MM SEA/SP 29 others CAP ELECTRODE CURVED 36MM SEA/SP CAP ELECTRODE D20 SEA/SP CAP ELECTRODE D30 SEA/SP CAP ELECTRODE D50 SEA/SP CAP ELECTRODE D70 SEA CAP ELECTRODE PEARL SEA/SP CAP ELECTRODE WAVE 13MM SEA/SP CAP ELECTRODE WAVE 36MM SEA/SP CHROMIX DEEP ACTION 30MM DEEP ACTION MAX 19MM INÜO NEUTRAL RETURN PLATE 34D NEUTRAL RETURN PLATE 34D-N NFUSE RES DEEP ACTION RES DEEP ACTION FOCUS RES ELECTRODE CURVED 23MM SEA/SP RES ELECTRODE D30 SEA/SP RES ELECTRODE D50 SEA/SP RES ELECTRODE D70 SEA SYMMED ELITE AESTHETIC2 refs SYMMED SMART HANDPIECE CAP2 refs SYMMED SMART HANDPIECE RES2 refs ULTRAPULSE & HYALMAX Z-CAP ZIONIC PRO MAX HP Z-RES ZIONIC PRO MAX HP ZIONIC AESTHETIC ZIONIC AESTHETIC HP	IIb MDR	EUDAMED record Report an error
Therapeutic lasers	Z120615	DIODE LASER AE 2XL HANDPIECE: 5000W-30x12MM-810NM DIODE LASER AE L HANDPIECE: 2000W-10x9MM-755NM DIODE LASER AE L HANDPIECE: 2000W-10x9MM-810NM DIODE LASER AE L HANDPIECE: 4000W-10x9MM-1060NM DIODE LASER AE XL HANDPIECE: 4000W-20x9MM-3WL 5 others DIODE LASER AE XL HANDPIECE: 4000W-20x9MM-755NM DIODE LASER AE XL HANDPIECE: 4000W-20x9mm-810nm ENEKA PRO AESTHETIC PLATE 19D ENEKA PRO93/42 (no longer marketed)	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Shock wave therapy equipment	Z12139001	HP-AT HP-V VAT120 TRANSMITTER VAT135 TRANSMITTER VAT215 TRANSMITTER 3 others VAT220 TRANSMITTER VAT315 TRANSMITTER VMAT PRO AESTHETIC	IIb MDR	EUDAMED record Report an error
Muscle reinforcement stimulators for innervated muscles	Z12062801	Z-EMS ZIONIC PRO MAX HP 1 Z-EMS ZIONIC PRO MAX HP 2 Z-EMS ZIONIC PRO MAX HP 3 Z-EMS ZIONIC PRO MAX HP 4	IIb MDR	EUDAMED record Report an error
General medicine therapeutic treatment instruments - hardware accessories	Z12040280	INÜO BLUNT TIP INÜO FINE TIP INÜO ULTRAFINE TIP	I MDR	EUDAMED record Report an error

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