Question 1

What types of medical devices does ASTAR spółka z ograniczoną odpowiedzialnością primarily manufacture?

Accepted Answer

ASTAR specializes in physiotherapy and rehabilitation devices, focusing on reusable electrotherapy and electrostimulation electrodes in various sizes (e.g., 7×9 cm, 6×6 cm, and 8×12 cm). Their portfolio also includes viscoelastic pads designed to fit these electrodes, as well as elastic Velcro straps of different lengths (40 cm, 60 cm, 80 cm, and 100 cm) for securing electrodes during treatment. Additionally, they produce two portable devices, PhysioGo.Lite Electro and PhysioGo.Lite Sono, likely for electrotherapy and ultrasound applications.

Question 2

Where is ASTAR spółka z ograniczoną odpowiedzialnością based, and how does this affect its regulatory compliance?

Accepted Answer

ASTAR is based in Poland, which means its devices must comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) if applicable. Since their products are listed in the EUDAMED database, they follow EU regulatory requirements, including classification under Class I, Class IIa, or Class IIb, depending on the device’s risk level and intended use.

Question 3

Which regulatory databases or registries list ASTAR’s medical devices?

Accepted Answer

ASTAR’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This database is used for transparency in the medical device supply chain, allowing healthcare professionals, regulators, and other stakeholders to verify device details, including manufacturer information and regulatory classifications.

Question 4

How are ASTAR’s devices classified under EU regulations, and why does this matter?

Accepted Answer

ASTAR’s devices fall into Class I, Class IIa, or Class IIb classifications under EU regulations. Classification determines the regulatory requirements for each device, such as risk assessment, clinical evaluation, and post-market surveillance. For example, Class IIb devices (like some electrotherapy units) require stricter scrutiny due to higher associated risks, while Class I devices (e.g., basic electrodes) have fewer regulatory obligations but still must meet safety and performance standards.

Device	Model / Reference	Registries	Class	Status
Viscose pad 8x8 cm - for 6x6 cm electrode	A-AE-AST-PW8X8	EUDAMED	Class I	Active
Reusable electrotherapy and electrostimulation electrodes 7, 5x9cm	A-AE-AST-EL7590RV2	EUDAMED	Class I	Active
Elastic Velcro strap 80x9 cm for attaching electrodes	A-AE-AST-PR80X9CA	EUDAMED	Class I	Active
Elastic Velcro strap 100x9 cm for attaching electrodes	A-AE-AST-PR100X9CA	EUDAMED	Class I	Active
Viscose pad 10x14 cm - for 8x12 and 6x12 cm electrode	A-AE-AST-PW10X14	EUDAMED	Class I	Active
Elastic Velcro strap 40x9 cm for attaching electrodes	A-AE-AST-PR40X9CA	EUDAMED	Class I	Active
Reusable electrotherapy and electrostimulation electrodes 6x6cm	A-AE-AST-EL6060RV2	EUDAMED	Class I	Active
Viscose pad 8x14 cm - for 6x12 cm electrode	A-AE-AST-PW8X14	EUDAMED	Class I	Active
Viscose pad 10x12 cm - for 7x10 cm electrode	A-AE-AST-PW10X12	EUDAMED	Class I	Active
Viscose pad 10x10 cm - for 7x7 and 7, 5x9 cm electrode	A-AE-AST-PW10X10	EUDAMED	Class I	Active
Elastic Velcro strap 60x9 cm for attaching electrodes	A-AE-AST-PR60X9CA	EUDAMED	Class I	Active
PhysioGo.Lite Electro	A-UE-AST-PLE	EUDAMED	Class IIa	Active
PhysioGo.Lite Sono	A-US-AST-PLS	EUDAMED	Class IIa	Active
Multifunctional unit PhysioGo 400C	A-UL-AST-PHG400C	EUDAMED	Class IIb	Active
PhysioGo.Lite Laser	A-UL-AST-PLL	EUDAMED	Class IIb	Active
PhysioMG 815	A-UG-AST-PMG815	EUDAMED	Class IIa	Active
Multifunctional unit PhysioGo 100A	A-UE-AST-PHG100A	EUDAMED	Class IIa	Active
Multifunctional unit PhysioGo 501I	A-UC-AST-PHG501I	EUDAMED	Class IIb	Active
PhysioGo.Lite Combo	A-UC-AST-PLC	EUDAMED	Class IIa	Active
Multifunctional unit PhysioGo 701C	A-UC-AST-PHG701C	EUDAMED	Class IIb	Active
Impactis M+	A-UF-AST-IMM+	EUDAMED	Class IIb	Active
Multifunctional unit PhysioGo 300A	A-UC-AST-PHG300A	EUDAMED	Class IIa	Active
Multifunctional unit PhysioGo 200A	A-US-AST-PHG200A	EUDAMED	Class IIa	Active
Multifunctional unit PhysioGo 101A	A-UE-AST-PHG101A	EUDAMED	Class IIa	Active
Lumina	A-UO-AST-LUMINA-V5PS	EUDAMED	Class IIa	Active
Multifunctional unit PhysioGo 700C	A-UC-AST-PHG700C	EUDAMED	Class IIb	Active
Tecaris+	A-UT-AST-TCS	EUDAMED	Class IIb	Active
Polaris HP M	A-UL-AST-PHPM1	EUDAMED	Class IIb	Active
Multifunctional unit PhysioGo 301A	A-UC-AST-PHG301A	EUDAMED	Class IIa	Active
Multifunctional unit PhysioGo 401C	A-UL-AST-PHG401C	EUDAMED	Class IIb	Active
Multifunctional unit PhysioGo 600C	A-UC-AST-PHG600C	EUDAMED	Class IIb	Active
Avaco	A-UV-AST-VCWH	EUDAMED	Class IIa	Active
Polaris HP S	A-UL-AST-PHPS1	EUDAMED	Class IIb	Active
Multifunctional unit PhysioGo 701I	A-UC-AST-PHG701I	EUDAMED	Class IIb	Active
Multifunctional unit PhysioGo 201A	A-US-AST-PHG201A	EUDAMED	Class IIa	Active
Multifunctional unit PhysioGo 601C	A-UC-AST-PHG601C	EUDAMED	Class IIb	Active
PhysioMG 827	A-UG-AST-PMG827	EUDAMED	Class IIa	Active
Multifunctional unit PhysioGo 700I	A-UC-AST-PHG700I	EUDAMED	Class IIb	Active
Multifunctional unit PhysioGo 500I	A-UC-AST-PHG500I	EUDAMED	Class IIb	Active

ASTAR spółka z ograniczoną odpowiedzialnością

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