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Zionic Pro Max

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref M105/1Model ZIONIC PRO MAX510(k) K243716Ref M105

by Termosalud, S.L.

Identity

Trade Name
ZIONIC PRO MAX EUDAMED
Device Name
ZIONIC PRO MAX EUDAMED
Model / Reference
ZIONIC PRO MAX EUDAMED
M105/1 EUDAMED
M105 EUDAMED

Identifiers

Primary DI / UDI-DI
08436601291448 EUDAMED
08436601291356 EUDAMED
Basic UDI-DI
843660129ZPMQ7 EUDAMED
510(k) Number
K243716 FDA 510(k)
FDA Product Code
PBX FDA 510(k)
EMDN Code
Z12040203,Z12062801 EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Market of Registration
Spain EUDAMED
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Zionic Pro Max by Termosalud, S.L. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Termosalud, S.L.
EUDAMED SRN
ES-MF-000019177

Sources (3)

  • EUDAMED 1dc6836f-1e40-4f81-ada0-ac4771c0bfbd 61 fields · synced Jul 29, 2026
  • FDA 510(k) K243716 24 fields · synced May 18, 2026
  • EUDAMED 31286382-38dc-45a9-a144-2d41b3ad2610 61 fields · synced Jul 16, 2026