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 - DK

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.

05700002192653

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.

57000021926SysONE-MRZ

Reference / catalog number

S02

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

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

Status

On the market

Quantity

1

Additional product description

System for HIFU treatment

Additional information URL

https://www.toosonix.com/

Clinical sizes

• Current — 1.5 MU107
• 50 MU27
• Voltage — 240 MU114

• 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.

Certificate health across this manufacturer's portfolio.