CINSB

Organization name

Cometa S.r.l.

SRN

IT-MF-000012630

Manufacturer status

Active

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

• CW007

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

  EUDAMED did not publish a description for this code.

Primary placement in Denmark; available across 30 countries total.

Trade name

not provided

UDI-DI code

+G082CINSB0

Basic UDI-DI

++G082CINSC2

Reference / catalog number

CINSB

Issuing entity

HIBCC

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The device is composed of the following main components: four pairs of insoles, two transmitters (one right and one left) and an induction charger (charging station). The device is capable of detecting inertial and baropodometric data and, through the transmitter, this information is sent to a PC. The device in question has a connection mode to the PC via Bluetooth; furthermore, it has an additional component, namely a key (Bluetooth dongle).

Additional information URL

https://www.cometasystems.com/

Clinical sizes

No clinical sizes registered for this device.

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

• Z12062602SENSOR-BASED INSOLES

Certificate health across this manufacturer's portfolio.