Question 1

What types of medical devices does Diagnostic Group LLC manufacture?

Accepted Answer

Diagnostic Group LLC specializes in audiometric testing devices, which include tone audiometers, impedance audiometers, battery-powered otoacoustic emission systems, and vestibulo-auditory analysis systems. These devices are designed to evaluate hearing function and diagnose vestibular disorders in clinical environments.

Question 2

Where is Diagnostic Group LLC based?

Accepted Answer

Diagnostic Group LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, particularly for FDA-related processes.

Question 3

Which regulatory registries list Diagnostic Group LLC’s devices?

Accepted Answer

Diagnostic Group LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify Class II medical devices, ensuring traceability and compliance with U.S. regulatory requirements.

Question 4

How are Diagnostic Group LLC’s devices classified?

Accepted Answer

Diagnostic Group LLC’s devices fall under Class II classification, which means they pose moderate risk and require special controls to ensure their safety and effectiveness. This classification is determined by the FDA based on the device’s intended use and potential health impact.

Device	Model / Reference	Registries	Class	Status
Maico	Digital Pilot Test	FDA UDI	Class II	Unknown
Maico	MB 11 BERAphone	FDA UDI	Class II	Unknown
Grason-Stadler	GSI AMTAS Flex	FDA UDI	Class II	Active
Grason-Stadler	GSI AMTAS Flex	FDA UDI	Class II	Active
Maico	MA 1	FDA UDI	Class II	Unknown
Grason-Stadler	GSI AudioStar Pro	FDA UDI	Class II	Unknown
Grason-Stadler	GSI AudioStar Pro	FDA UDI	Class II	Active
Maico	MB 11 Classic	FDA UDI	Class II	Unknown
Grason-Stadler	GSI AMTAS Flex	FDA UDI	Class II	Active
Grason-Stadler	GSI 39	FDA UDI	Class II	Active
Grason-Stadler	GSI Pello	FDA UDI	Class II	Active
Maico	MA 42	FDA UDI	Class II	Unknown
Tremetrics	RA800	FDA UDI	Class II	Unknown
Maico	MA 25	FDA UDI	Class II	Unknown
Grason-Stadler	GSI Novus	FDA UDI	Class II	Active
Grason-Stadler	GSI 18	FDA UDI	Class II	Active
Grason-Stadler	GSI TympStar Pro	FDA UDI	Class II	Active
Grason-Stadler	GSI Audera Pro	FDA UDI	Class II	Active
Tremetrics	HT Wizard Ultra	FDA UDI	Class II	Unknown
Maico	MA 27	FDA UDI	Class II	Unknown
Tremetrics	RA300	FDA UDI	Class II	Unknown
Grason-Stadler	GSI Audera	FDA UDI	Class II	Unknown
Tremetrics	RA650	FDA UDI	Class II	Unknown
Maico	EroScan	FDA UDI	Class II	Unknown
Grason-Stadler	GSI Audioscreener +	FDA UDI	Class II	Unknown
Grason-Stadler	GSI AMTAS Flex	FDA UDI	Class II	Active
Maico	easyTymp	FDA UDI	Class II	Unknown
Tremetrics	HT Wizard PC	FDA UDI	Class II	Unknown
Maico	MA 41	FDA UDI	Class II	Unknown
Grason-Stadler	GSI Allegro	FDA UDI	Class II	Active
Grason-Stadler	GSI Corti	FDA UDI	Class II	Active
Maico	easyTymp Pro Version	FDA UDI	Class II	Unknown
Maico	MA 52	FDA UDI	Class II	Unknown
Ma61, Ma62, Ma63 Family Of Portable Audiometers	K092244	FDA 510(k)	Class II	Active

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