OTODYNAMICS LTD
GB-MF-000018964 · United Kingdom · Hatfield
OTODYNAMICS LTD is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 28 |
|---|
Most frequent device types declared: ADV-S, FLX-S, LE-ST, LTC-ABR, LTC-SD.
Among these devices, 28 are declared active, 28 with a measuring function.
Authorised representative in the Union: MDSS GmbH.
Devices declared under this manufacturer
- Otodynamics
Showing 12 of 28 declared devices.
Catalogue references include ADV-S, FLX-S, LE-ST, LTC-SD, LTC-ST+ABR, NOVA-CLN-DPTE +ABR.
European nomenclature codes declared: Z12149001, Z12140302.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OTODYNAMICS, LTD. (GB) · FDA 8021990 |
| Devices in EUDAMED | 28 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 28 |
|---|---|
| Found in the U.S. device database | 10 |
| Share | 35.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OTODYNAMICS LTD. |
North American profile: Both markets. OTODYNAMICS LTD is registered in both the United States and Canada.