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Amplivox, Ltd.

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Amplivox, Ltd. is a medical device manufacturer, with 19 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (FDA Class II; EU Class IIa) as of 13 Nov 2026.

Devices
19

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 15
  • FDA GUDID 15
  • FDA 510(k) 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 18
  • EU Class IIa 1
Top EMDN categories
Sites and related companies

What Amplivox, Ltd. makes

Amplivox, Ltd. manufactures diagnostic equipment for hearing and balance assessment, including vestibulo-auditory analysis systems, tone audiometers, and impedance audiometers. These devices are designed to measure auditory function, middle-ear impedance, and vestibular responses in clinical settings. The portfolio includes standalone and integrated systems for audiological testing and evaluation.

The company’s products fall under FDA Class II devices and are authorised through the 510(k) premarket notification process and the FDA’s Unique Device Identifier (UDI) system. These devices are listed in the FDA’s regulatory databases, ensuring compliance with US medical device regulations. The manufacturer operates from the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue19

Newest first, rows 1-19 of 19

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  • Anova Ref 8538354

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Amplivox Otowave 102

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Amplivox Otowave 302

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Amplivox Otowave 202

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Amplivox Model 240

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Amplivox Model 270

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Amplivox PC850

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Amplivox Otowave 302

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Amplivox Model 170

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Amplivox Otosure

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Amplivox Otowave 102-C

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Amplivox Model 116

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Amplivox Otowave 302+

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Amplivox Model 260

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Amplivox Model 270+

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Amplivox modelONE

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Amplivox Otowave 102 Hand Held Portable Tympanometer Ref K081841

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Otowave 202 Portable Tympanometer Ref K150163

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Otowave 302 Portable Tympanometer Ref K171265

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-19 of 19

Sites1

Frequently asked questions

How many devices does Amplivox, Ltd. have in the registry?

The registry currently lists 19 devices for Amplivox, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Amplivox, Ltd.'s devices?

Among its 19 most recently registered devices, Amplivox, Ltd. has devices listed in EUDAMED (15 devices), FDA 510(k) (3 devices) and FDA GUDID (15 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Amplivox, Ltd.'s devices fall under?

Among its 19 most recently registered devices, the classes recorded for Amplivox, Ltd.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Amplivox, Ltd. in the registry?

The most recently registered devices listed for Amplivox, Ltd. include Anova, Amplivox Otowave 102, Amplivox Otowave 302 and Amplivox Otowave 202.

Generated automatically from registry data and not verified by a human reviewer.