A-UL-AST-PHPS1

Organization name

ASTAR spółka z ograniczoną odpowiedzialnością

SRN

PL-MF-000010564

Manufacturer status

Active

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

• CW014

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.
• CW013

  EUDAMED did not publish a description for this code.

Primary placement in Poland; available across 7 countries total.

Trade name

not provided

UDI-DI code

05903641500661

Basic UDI-DI

590364150PHPKR

Reference / catalog number

A-UL-AST-PHPS1

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Laser therapy unit Polaris HP is an active, therapeutic, non-invasive medical device. It is intended for carrying out treatment procedures using high-power laser radiation within the invisible range with a visible pilot beam or biostimulating laser radiation within the visible and invisible range using applied laser applicators. The laser radiation is delivered through direct contact method with non-injured skin or without a contact. Parts of the body intended for treatments with Polaris HP 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, circulatory and lymphatic system and/or skin.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 15.1 MU10
• 36.1 MU10
• 30.4 MU10

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

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

• Z120615THERAPEUTIC LASERS

Certificate health across this manufacturer's portfolio.