Question 1

What does FAE Famed Łódź S.A. manufacture?

Accepted Answer

FAE Famed Łódź S.A. manufactures operating room light systems, including models such as STRATOS S-1, SOLIS 130 Lampa operacyjna, IGNIS 160C / SOLIS 130C, SOLIS 30 F, IGNIS 160 C, SOLIS 130 F, SOLIS 130C/ SOLIS 130C, IGNIS 160/160 C, IGNIS 160CAM/TV/160 C, HELIOS 160/SOLIS 130C, SOLIS 160/60 C, and HELIOS 160 W.

These devices are classified as Class I and are listed in the Eudamed registry. The company is based in Poland.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is FAE Famed Łódź S.A. based?

Accepted Answer

FAE Famed Łódź S.A. is based in Poland, as indicated by the COUNTRY field in the device data, which specifies 'PL' as the country code for Poland. This confirms the company's location within the European Union.

Question 3

In which registry are the devices of FAE Famed Łódź S.A. listed?

Accepted Answer

The devices manufactured by FAE Famed Łódź S.A. are listed in the Eudamed registry, as explicitly stated in the DEVICE DATA under 'LISTED IN: eudamed'. Eudamed is the European database for medical devices, and inclusion here indicates that the company's devices are registered in this system.

Question 4

How are the devices of FAE Famed Łódź S.A. classified?

Accepted Answer

The devices produced by FAE Famed Łódź S.A. are classified as Class I, according to the DEVICE CLASSES field in the provided data. Class I is the lowest risk category for medical devices under the EU regulatory framework, and this classification applies to all the operating room light systems listed as examples.

Device	Model / Reference	Registries	Class	Status
Stratos S-1	STRATOS S -1	EUDAMED	Class I	Active
SOLIS 130 Lampa operacyjna	SOLIS 130W /SOLIS130W	EUDAMED	Class I	Active
Ignis 160c / Solis 130c	IGNIS 160C / SOLIS 130C	EUDAMED	Class I	Active
Solis 30 F	SOLIS 30 F	EUDAMED	Class I	Active
Ignis 160 C	IGNIS 160 C	EUDAMED	Class I	Active
Solis 130 F	SOLIS 130 F	EUDAMED	Class I	Active
Solis 130c/ Solis 130c	SOLIS 130C /SOLIS 130C	EUDAMED	Class I	Active
Ignis 160/160 C	IGNIS 160/160 C	EUDAMED	Class I	Active
Ignis 160cam/Tv/160 C	IGNIS 160CAM/TV/160 C	EUDAMED	Class I	Active
Helios 160/Solis 130c	HELIOS 160/SOLIS 130C	EUDAMED	Class I	Active
Solis 160/60 C	SOLIS 160/60 C	EUDAMED	Class I	Active
Helios 160 W	HELIOS 160 W	EUDAMED	Class I	Active
Ignis 160cam / Solis 130c	IGNIS 160CAM / SOLIS 130C	EUDAMED	Class I	Active
Helios 160 F	HELIOS 160 F	EUDAMED	Class I	Active
Solis 160 W	SOLIS 160 W	EUDAMED	Class I	Active
Stratos S-2	STRATOS S-2	EUDAMED	Class I	Active
Solis 60/60 W	SOLIS 60*60 W	EUDAMED	Class I	Active
Helios-M 160/160 C	HELIOS-M 160/160 C	EUDAMED	Class I	Active
Solis 160 C	SOLIS 160 C	EUDAMED	Class I	Active
Solis 130 W	SOLIS 130 W	EUDAMED	Class I	Active
Solis 160 F	SOLIS 160 F	EUDAMED	Class I	Active
Solis 60/60 C	SOLIS 60/60 C	EUDAMED	Class I	Active
Solis 30 Fa	SOLIS 30 FA	EUDAMED	Class I	Active
Solis 160 Fa	SOLIS 160 FA	EUDAMED	Class I	Active
Ignis 160 W	IGNIS 160 W	EUDAMED	Class I	Active
Ignis 160cam/Tv C	IGNIS 160CAM/TV C	EUDAMED	Class I	Active
Helios 160 C	HELIOS 160 C	EUDAMED	Class I	Active
Helios-M 160 C	HELIOS-M 160 C	EUDAMED	Class I	Active
Stratos A-1	STRATOS A-1	EUDAMED	Class I	Active
Helios 160 Fa	HELIOS 160 FA	EUDAMED	Class I	Active
Solis 60/60 F	SOLIS 60/60 F	EUDAMED	Class I	Active
Helios-M 160 W	HELIOS-M 160 W	EUDAMED	Class I	Active
Helios 160/60 C	HELIOS 160/60 C	EUDAMED	Class I	Active
Solis 30 W	SOLIS 30 W	EUDAMED	Class I	Active
Helios-M 160 F	HELIOS-M 160 F	EUDAMED	Class I	Active
Ignis 160 F	IGNIS 160 F	EUDAMED	Class I	Active
Helios-M 160/60 C	HELIOS-M 160/60 C	EUDAMED	Class I	Active
Solis 160/160 C	SOLIS 160/160 C	EUDAMED	Class I	Active
Solis 130fa	SOLIS 160FA	EUDAMED	Class I	Active
Ignis 160cam/160 C	IGNIS 160CAM/160 C	EUDAMED	Class I	Active
Stratos U	STRATOS U	EUDAMED	Class I	Active
Solis 60 F	SOLIS 60 F	EUDAMED	Class I	Active
Stratos P	STRATOS P	EUDAMED	Class I	Active
Solis 130 C	SOLIS 130 C	EUDAMED	Class I	Active
Solis 60 C	SOLIS 60 C	EUDAMED	Class I	Active
Ignis 160 Fa	IGNIS 160 FA	EUDAMED	Class I	Active
Solis 30 C	SOLIS 30 C	EUDAMED	Class I	Active
Stratos A-2	STRATOS A-2	EUDAMED	Class I	Active
Solis 60 W	SOLIS 60 W	EUDAMED	Class I	Active
Helios-M 160/Solis 130c	HELIOS-M 160/SOLIS 130C	EUDAMED	Class I	Active

FAE Famed Łódź S.A.

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