APM10900.201

Organization name

LED SpA

SRN

IT-MF-000012232

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 3 countries total.

Trade name

not provided

UDI-DI code

08033638325421

Basic UDI-DI

803363832HFS00144

Reference / catalog number

APM10900.201

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

COOLINGBIS 1.0 is a radio frequency (RF) generator capable of delivering electrical energy to tissue, producing a localised thermal effect. It uses electric current in the frequency range typical of electrosurgery (300 kHz - 4 MHz).

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.

• Z12010902ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE