FDA UDI
In Commercial Distribution
🇺🇸 United States
EUROMI
DI: 03701416203388
·
Model: Eva sp1 - 110V
·
Euromi
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EUROMI
- Primary DI
- 03701416203388
- Version / Model
- Eva sp1 - 110V
- Catalog Number
- 1114sp1110v
- 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
- 1
- Public Version Date
- 2025-09-04
- Public Version Status
- New
- Public Device Record Key
- 3eaaaca0-36fd-4a2c-9a8b-5d50ca9bdad7
Device Description
The Eva sp® 1 system is the basic system of the Eva sp® range. It regulates compressed air supplied to the evamatic®. Thus, Eva sp® 1 allows a Nutational Infrasonic Liposculpture (N.I.L® technique). Thanks to the infiltration cannula provided with it, and the use of an external pressure system (peristaltic pump), infiltration is qualitative and uniform. This system is designed for practitioners already using their own infiltration and aspiration 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 | 03701416203388 | GS1 |