Skip to content

Euromi EVA SP6 Suction System

by Euromi S.A EUDAMED510(k)

Active European Union and United States

510(k) K101413

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK101413 Date16 Dec 2010ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

Full name
Euromi Eva SP6
510(k) Number
FDA Product Code
QPB
Device Class
Class II
Regulation
21 CFR Part 878.5040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Euromi EVA SP6 is a System, Suction, Lipoplasty for Removal, designed for liposuction procedures. It combines suction technology with manual or power-assisted techniques to remove excess fat from targeted areas, aiding in body contouring and cosmetic enhancement.

This device is supplied as a reusable system, intended for use in clinical settings such as surgical centers and hospitals. It adheres to FDA 510(k) clearance and MDD regulations, with a classification under Device Class II. The system requires proper sterilization and maintenance as per manufacturer guidelines, ensuring safe and effective performance for plastic surgery applications.

Other devices from Euromi S.A

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is the Euromi EVA SP6 designed for single-use or can it be reused in a clinical setting?

    The Euromi EVA SP6 is supplied as a reusable system, intended for use in clinical settings like surgical centers and hospitals. Since it is reusable, it requires proper sterilization and maintenance as outlined by the manufacturer to ensure safe and effective performance during liposuction procedures.

  • What types of liposuction techniques does the Euromi EVA SP6 support, and how is it used in body contouring?

    The Euromi EVA SP6 combines suction technology with both manual and power-assisted techniques, making it versatile for removing excess fat from targeted areas. This dual-functionality aids in body contouring and cosmetic enhancement by allowing clinicians to choose the method best suited for the procedure.

  • What regulatory pathways has the Euromi EVA SP6 followed, and what does this mean for its use in the U.S.?

    The device has undergone FDA 510(k) clearance and adheres to MDD (Medical Device Directive) regulations, classifying it as Device Class II. This means it has been evaluated for safety and effectiveness under U.S. and European regulatory frameworks, ensuring compliance for use in clinical settings like hospitals and surgical centers.

  • Are there different sizes or models available for the Euromi EVA SP6, and how might this affect its application?

    While the provided data does not specify exact sizes or model variations, the product code (QPB) and registration numbers indicate it is categorized under System, Suction, Lipoplasty for Removal, suggesting it may offer adaptability for different liposuction needs. Clinicians should refer to the manufacturer’s documentation for precise sizing or model-specific details to match patient requirements.