Organization name

High technology Products SLU

SRN

ES-MF-000024776

Manufacturer status

Active

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• Consult instructions for use

  Consult IFU

Primary placement in Germany; available across 27 countries total.

Trade name

CoolTech Define massager applicator

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.

08437020651288

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-08437020651288

Reference / catalog number

200000278

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

The removable and independent applicators make it possible to work on up to four zones simultaneously. They are specially designed and developed to temporarily suction tissue in the treatment zone. They immobilise and isolate the adiposity from the rest of the tissues, enabling more precise and deeper cooling. Depending on the area to be treated, the patient's fat type and clinical protocol instructions, you must use one or another applicator. Each of the applicators is intended for a different treatment areas and fat type. Suction slot: the tissue is suctioned to draw the skin and adipose tissue into the inner cavity through this orifice located inside the applicator, where they come into contact with the cooling surface. Internal cooling surface: total contact area inside the applicator that applies cooling during treatment.

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.

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

• Class IIa medical devices in EUDAMED

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