Organization name

Aesthetic Rent S.L.

SRN

ES-MF-000047678

Manufacturer status

Active

No certificate specifically references this device's Basic UDI-DI.

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  Refer to the Instructions for Use for contraindications, warnings and precautions.

Primary placement in Spain; available across 32 countries total.

Trade name

DEEP REGEN I

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08437026917258

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

8437025783DS014Q

Reference / catalog number

DRE002

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Non-medical device based on low-frequency, low-intensity multifocal ultrasound with an effect on inflammatory and fibrotic processes of adipose and connective tissue.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• X0402EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE FOR LIPOLYSIS

• Class IIb medical devices in EUDAMED