Microwave Therapy Device MICRO THERMY

Organization name

OG Wellness Technologies Co., Ltd. Headquarters

SRN

JP-MF-000002613

Manufacturer status

Active

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

• CW018

  EUDAMED did not publish a description for this code.

Primary placement in Bulgaria; available across 3 countries total.

Trade name

Microwave Therapy Device MICRO THERMY

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.

04571292660693

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-04571292660693

Reference / catalog number

－

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

This product achieves hyperthermal effect by irradiating microwaves to the affected area heating the deep tissue for pain relief. The applicator moves flexibly. It can be used for both small parts such as the wrist and knee and for large parts such as the lower back. There are two output modes: continuous output mode and intermittent output mode. The output control function limits the maximum output.

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.

• Z120608MICROWAVE THERAPY EQUIPMENT

• Class IIa medical devices in EUDAMED

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