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 14 countries total.

Trade name

PhysioGo.Lite Electro

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.

05903641500906

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.

590364150PLEKF

Reference / catalog number

A-UE-AST-PLE

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

PhysioGo.Lite Electro is an active, non-invasive therapeutic device, intended for carrying out treatment procedures using bipolar (bidirectional) and unipolar (unidirectional) low frequency currents, bipolar (bidirectional) and unipolar (unidirectional) medium frequency currents. Treatments are performed by direct contact method with non-injured skin. Parts of the body intended for treatments with PhysioGo.Lite Electro are back, upper limbs (shoulder, arm, forearm, hand), lower limbs (hip, thigh, shank, foot), neck and face for interaction with body tissues such as muscle, skeletal, nervous system and/or skin.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 25 MU10
• 16 MU10
• 27 MU10

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

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

• Z120601ELECTROTHERAPY EQUIPMENT (INCLUDED TENS)

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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