System ONE-M - IT

Organization name

TOOsonix A/S

SRN

DK-MF-000014211

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Denmark; available across 32 countries total.

Trade name

System ONE-M - IT

UDI-DI code

05700002312709

Basic UDI-DI

57000021926SysONE-MRZ

Reference / catalog number

S02

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

HIFU device for dermatological therapy

Additional information URL

https://www.toosonix.com/

Clinical sizes

• input power — 240 MU114
• Current — 1.5 MU107
• 50 MU27

• 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

Certificate health across this manufacturer's portfolio.