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Otodynamics

Active in EUDAMED

Registered as OTODYNAMICS LTD in EUDAMED

Also registered as OTODYNAMICS LIMITED, OTODYNAMICS LTD

United Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000018964

Otodynamics is a medical device manufacturer based in the United Kingdom, with 250 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa and I) as of 13 Nov 2026.

Devices
250
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 213
  • EUDAMED 97
  • FDA 510(k) 8

A device listed in two registries counts in both.

Device classes
  • FDA Class II 214
  • EU Class IIa 27
  • EU Class I 9
Top EMDN categories
Identifiers
  • EUDAMED SRN GB-MF-000018964

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment

What Otodynamics makes

Otodynamics manufactures audiometric and otoacoustic emission devices, including battery-powered and line-powered systems for measuring hearing function. Their portfolio includes evoked-potential audiometers for auditory brainstem response testing and accessories like probe assemblies, service kits, and wireless charging pads. Clinical screening tools, such as DPOAE and AABR screeners, are also part of their offerings, alongside hardware components like printer attachments and probe stands.

All devices are classified as Class II under regulatory frameworks, with authorisations recorded via FDA 510(k) submissions and FDA Unique Device Identifiers (UDI). The company’s products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device regulations. Otodynamics operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue250

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
GB-MF-000018964
EU VAT number
GB 539 9876 66
EUDAMED status
Active
EUDAMED registered name
OTODYNAMICS LTD
Registered address
30-38, Beaconsfield Road, AL10 8BB, Hatfield, United Kingdom (ex Northern Ireland)
Phone
+44 1707 267540
PRRC contact
Daniel Budd(public in EUDAMED)

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Otodynamics, Ltd. HATFIELD, HERTS Hertfordshire · GB Other ID 2939

Frequently asked questions

How many devices does Otodynamics have in the registry?

The registry currently lists 250 devices for Otodynamics. Devices recorded under merged duplicate company entries are counted once.

Which registries list Otodynamics's devices?

Among its 50 most recently registered devices, Otodynamics has devices listed in EUDAMED (24 devices) and FDA GUDID (36 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Otodynamics's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Otodynamics's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Otodynamics in the registry?

The most recently registered devices listed for Otodynamics include NHSP Otoport/Otocheck Download Cable (non-locking), USB Cable (A to C) length 1 metre, UPD Ear Probe and UPS Ear Probe.

Which FDA establishments are linked to Otodynamics?

1 FDA establishment is linked to Otodynamics in the registry; they are listed on the company page.

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