FDA.report

EUROMI

Primary DI
03701416200035
Brand
EUROMI
Company
Euromi
Model
PNEUMATIC HANDPIECE EVAMATIC® 5
Catalog number
1101EKL5
Device description
The evamatic® is a handpiece equipped with a pneumatic motor which will drive the end of the cannula in a nutation movement (precession movement) allowing the grease to be gently extracted (N.I.L.® technique). Learn more about the N.I.L.® technique.
Published
2025-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications

CodeDeviceSpecialtyClass
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03701416200035PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03701416203388EUROMIEva sp1 - 110V1114sp1110v2025-08-27
03701416203401EUROMIEva sp6 - 110V 1114sp616110V 2025-08-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
03701416203388EUROMIEuromiQPB2025-08-27
03701416203401EUROMIEuromiQPB2025-08-27
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