EUROMI

Primary DI
03701416203401
Brand
EUROMI
Company
Euromi
Model
Eva sp6 - 110V
Catalog number
1114sp616110V
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 (
Published
2025-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010311000LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICEEuromi S.A2001-06-29QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701416203401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701416203401037014162034013701416203401

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
505804302
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701416200035EUROMIPNEUMATIC HANDPIECE EVAMATIC® 5 1101EKL5 2025-08-27
03701416203388EUROMIEva sp1 - 110V1114sp1110v2025-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701416200035EUROMIEuromiQPB2025-08-27
03701416203388EUROMIEuromiQPB2025-08-27
00847399017413MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017420MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017437MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017444MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017451MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017468MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017475MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017482MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017499MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017505MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017512MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399018960MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
14260170880045WAL applicatorHuman Med AGQPB2025-07-30
04260170880352Hydrophobic Filter-setHuman Med AGQPB2025-07-30
14260170880502WAL applicatorHuman Med AGQPB2025-07-30
04260170880802WAL Infiltration CannulaHuman Med AGQPB2025-07-30
04260170880819WAL CannulaHuman Med AGQPB2025-07-30
04260170880840WAL Infiltration CannulaHuman Med AGQPB2025-07-30
04260170880857WAL CannulaHuman Med AGQPB2025-07-30
04260170880871WAL CannulaHuman Med AGQPB2025-07-30
04260170880895WAL CannulaHuman Med AGQPB2025-07-30
04260170880918WAL CannulaHuman Med AGQPB2025-07-30
04260170880932WAL CannulaHuman Med AGQPB2025-07-30
04260170880956WAL CannulaHuman Med AGQPB2025-07-30
04260170880994Biofill CannulaHuman Med AGQPB2025-07-30
04260170881014Biofill Infiltration CannulaHuman Med AGQPB2025-07-30
04260170881038Biofill CannulaHuman Med AGQPB2025-07-30
04260170881052Biofill CannulaHuman Med AGQPB2025-07-30