CRISTAL Pro

Organization name

DELEO S.A.S.

SRN

FR-MF-000000215

Manufacturer status

Active

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

• Consult instructions for use

Primary placement in France; available across 12 countries total.

Trade name

CRISTAL Pro

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.

36657490008884

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.

B-36657490008884

Reference / catalog number

CRISTAL Pro MDD

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 IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

CRISTAL PRO® is a class IIa medical device whose medical indication is: •Non-invasive cryolipolysis for diminishing localized subareolar fat for male patients with pseudogynecomastia CRISTAL PRO® also has non-medical indications. It is effective for: •The reduction of localized fatty deposits. CRISTAL PRO® can cool, the localized fat fold, from 0° down to -12 °C without damaging other surrounding tissue thanks to the cryoprotective gel pad. CRISTAL PRO® can generate suction, from 50 to 300 mbar, to drag the fat fold inside the applicator. CRISTAL PRO® allows you to set 1,2,3 or 4 applicators, working simultaneously or not, to treat several body areas at the same time. CRISTAL PRO® is exclusively intended for healthcare professionals, and its use is reserved for people trained by DELEO S.A.S. The users received appropriate training on the conditions to safely use the device.

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 IIa medical devices in EUDAMED

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