Tecaris+

Organization name

ASTAR spółka z ograniczoną odpowiedzialnością

SRN

PL-MF-000010564

Manufacturer status

Active

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

• Type BF applied part

  -

• Refer to instruction manual/booklet

  -

Primary placement in Poland; available across 9 countries total.

Trade name

Tecaris+

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.

05903641501460

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.

590364150TCUN

Reference / catalog number

A-UT-AST-TCS

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The device is a generator of RF sinusoidal alternating current (300, 500, 750 or 1000 kHz) to locally increase the temperature in the treatment area. The electric current is delivered to the patient through direct contact method with non-injured skin, using active and neutral electrodes and a coupling medium, such as RF therapy cream. Parts of the body intended for treatments with Tecaris are back, upper limb (shoulder, arm, forearm, hand), lower limb (hip, thigh, shank, foot), neck and face for interaction with body tissues such as muscle, skeletal, nervous, circulatory and lymphatic system and/or skin.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 15.1 MU10
• 30.4 MU10
• 36.1 MU10

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• Z12069099VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.