Question 1

What types of medical devices does ILO electronic GmbH manufacture?

Accepted Answer

ILO electronic GmbH specializes in endoscopic and otoscopic devices. Their portfolio includes endoscope video cameras, endoscopic light source units that operate on line power, endoscopic video image processing units, and integrated systems combining video processing with lighting. Additionally, they produce direct-view otoscopes for clinical examinations. These devices are designed for use in medical procedures requiring visual inspection of internal body structures.

Question 2

Where is ILO electronic GmbH based?

Accepted Answer

ILO electronic GmbH operates from the United States. While the company name includes 'GmbH,' which is a German legal term, their primary business activities and regulatory listings are associated with the US market.

Question 3

Which regulatory registries list ILO electronic GmbH’s devices?

Accepted Answer

ILO electronic GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring traceability and compliance with regulatory requirements.

Question 4

How are ILO electronic GmbH’s devices classified under FDA regulations?

Accepted Answer

ILO electronic GmbH’s devices fall under two classification categories under FDA regulations: Class I and Class II. Class I devices are generally considered low-risk and typically require only general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks.

Device	Model / Reference	Registries	Class	Status
Ilo	LED 3000plus	EUDAMEDFDA UDI	Class II	Active
Ilo	EcoHD II	EUDAMEDFDA UDI	Class I	Active
Ilo	M-X 300A-LED	FDA UDI	Class II	Active
Ilo	TRIstarHD USB	EUDAMEDFDA UDI	Class I	Active
Ilo	LED 50	EUDAMEDFDA UDI	Class II	Active
Ilo	M-LED 3000Tplus	EUDAMEDFDA UDI	Class II	Active
Ilo	EcoHD	EUDAMEDFDA UDI	Class I	Active
Ilo	M-CAM 3HD	EUDAMEDFDA UDI	Class I	Active
Ilo	X 300AT-LED	FDA UDI	Class II	Active
Ilo	M-CAM 1HD	EUDAMEDFDA UDI	Class I	Active
Ilo	M-LED 2500	EUDAMEDFDA UDI	Class II	Active
Ilo	LED50-EcoHD II	FDA UDI	Class I	Active
Ilo	LED 3000Tplus	EUDAMEDFDA UDI	Class II	Active
Ilo	LED 50-HD	EUDAMEDFDA UDI	Class I	Active
Ilo	M-LED 3000plus	EUDAMEDFDA UDI	Class II	Active
Ilo	TRIstar 4K	FDA UDI	Class I	Active
Ilo	M-X 300A	FDA UDI	Class II	Active
Ilo	EcoHD-USB	FDA UDI	Class I	Active
Ilo	TRIstarHD	EUDAMEDFDA UDI	Class I	Active
Ilo	M-X 300M-LED	FDA UDI	Class II	Active
Ilo	M-EcoHD	EUDAMEDFDA UDI	Class I	Active
Ilo	Swift 1HD USB	EUDAMEDFDA UDI	Class I	Active
Ilo	M-CAM 1HD USB	EUDAMEDFDA UDI	Class I	Active
Ilo	Swift 1HD	EUDAMEDFDA UDI	Class I	Active
Ilo	M-CAM 4K	EUDAMEDFDA UDI	Class I	Active
Ilo	X 300AT	FDA UDI	Class II	Active
Ilo	LED50-HD II RW US	FDA UDI	Class I	Active
Ilo	M-X 300M	FDA UDI	Class II	Active
Ilo	Camera head LED50-HDII	FDA UDI	Class I	Active
Ilo	M-X 300AT	FDA UDI	Class II	Active
Ilo	X 300A-LED	FDA UDI	Class II	Active
Ilo	M-EcoHD-USB	EUDAMEDFDA UDI	Class I	Active
Ilo	X 300M-LED	FDA UDI	Class II	Active
Ilo	X 300M	FDA UDI	Class II	Active
Ilo	LED 2500	EUDAMEDFDA UDI	Class II	Active
Ilo	M-CAM 4K USB	EUDAMEDFDA UDI	Class I	Active
Ilo	M-X 300AT-LED	FDA UDI	Class II	Active
Ilo	M-CAM 3HD USB	EUDAMEDFDA UDI	Class I	Active
Ilo	Nex-Gen-HDoto	FDA UDI	Class I	Active
Ilo	Camera head LED50-HDII	FDA UDI	Class I	Active
Ilo	TRIstar 4K USB	EUDAMEDFDA UDI	Class I	Active
Ilo	LED50-HD II	EUDAMEDFDA UDI	Class I	Active
Ilo	X 300A	FDA UDI	Class II	Active
Ilo	LED 50-HD-USB	FDA UDI	Class I	Active
Ilo	M-EcoHD II	EUDAMEDFDA UDI	Class I	Active

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