Organization name

ASTAR spółka z ograniczoną odpowiedzialnością

SRN

PL-MF-000010564

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 Poland; available across 21 countries total.

Trade name

Viscose pad 8x8 cm - for 6x6 cm electrode

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.

05903641500302

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.

590364150PWVJ

Reference / catalog number

A-AE-AST-PW8X8

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Electrotherapy and electrostimulation reusable electrode is inserted into viscose pad for improving the quality of the contact with the patient body during treatment session. Treatments are performed by direct contact method with intact skin. Parts of the body intended for treatments 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

• 8 MU10
• 8 MU10

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

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

• Z12062885NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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