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EUDAMED last updated this device on May 22, 2024
590364150PHPKRPolaris HP S is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by ASTAR spółka z ograniczoną odpowiedzialnością. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05903641500661A-UL-AST-PHPS1PL-MF-000010564(01)05903641500661
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 warnings recorded — scroll inside the panel to see all entries.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Poland; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | Aug 2, 2023 | Still on market |
| Denmark | Nov 28, 2023 | Still on market |
| EL | Aug 27, 2024 | Still on market |
| Hungary | Aug 27, 2024 | Still on market |
| Iceland | Aug 27, 2024 | Still on market |
| Lithuania | Aug 27, 2024 | Still on market |
| Romania | Aug 27, 2024 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z120615THERAPEUTIC LASERSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →590364150PMGKNOn the marketPhysioMG 827590364150PMGKNOn the marketPolaris HP M590364150PHPKROn the marketReusable electrotherapy and electrostimulation electrodes 6x6cm590364150ELV2C3On the marketReusable electrotherapy and electrostimulation electrodes 7,5x9cm590364150ELV2C3On the marketStainless steel point electrode - 10 mm diameter590364150ELV2C3On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
HZ 1962094-1SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →