EUROMI

Basic Information

• Brand Name: EUROMI
• Primary DI: 03701416203401
• Version / Model: Eva sp6 - 110V
• Catalog Number: 1114sp616110V
• Company Name: Euromi
• Labeler DUNS: 505804302
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-27
• Public Version: 2
• Public Version Date: 2025-10-22
• Public Version Status: Update
• Public Device Record Key: 23b72e2b-68ce-42dd-b9c9-437c878d9496

Device Description

Eva sp® 6 allows not only a quantitative nutational infrasonic infiltration but also a nutational infrasonic liposculpture. The advantages of the Eva sp® 6 are numerous: • Connective tissues are preserved: better skin retraction, less bleeding, oedema, bruising and pain. The recovery time is shorter. • The infiltration is constant, deep, homogeneous and controlled, regardless of the type of fat. • The infrasonic frequency (<25 Hz) is comfortable for the patient. • The work for the surgeon is easier and more precise. It is also shorter. • The surgeon has better access to delicate and difficult areas. • The Eva sp® 6 is compatible with N.L.F. System®

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	878.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36894	Liposuction system	An assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03701416203401	GS1