Singapore HSA registration DE0501211
Otodynamics Echoport USB Otoacoustic Emission (OAE) Instrument
Singapore·CLASS B·Otodynamics Ltd·Registered February 12, 2018Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0501211
- Registration Date
- February 12, 2018
- Retention Due Date
- February 11, 2026
Product description
The Otodynamics Echoport with V6 or EZ·Screen software is indicated when there is a need to screen for hearing disorders by objective and non-invasive means. TEOAE and DPOAE screening test results are automatically interpreted and a clear ‘Pass’ or “Refer’ result is presented to the user who will be an audiologically trained screener, audiologist or medical professional. The device is indicated when the patient is unable to give reliable voluntary responses to sound, especially infants. Use of the device facilitates the early detection of hearing loss and its characterisation. The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterisation and monitoring of the functional status of the peripheral auditory function. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.
Product Owner
- Name
- Otodynamics Ltd
- Short Name
- Surgipro
- Address
- 30-38 Beaconsfield Road, Hatfield Herts, AL10 8BB, UNITED KINGDOM
Registrant
- Name
- Surgipro Pte Ltd
- Address
- 23 WOODLANDS INDUSTRIAL PARK E1, ADMIRALTY INDUSTRIAL PARK, #03-05, SINGAPORE 757741
Importer
- Name
- Surgipro Pte Ltd
- Address
- 23 WOODLANDS INDUSTRIAL PARK E1, ADMIRALTY INDUSTRIAL PARK, #03-05, SINGAPORE 757741
Model information
- Model Name(s)
- T11M TEOAE probe tip R9M TE+DPOAE probe tip R11M TE+DPOAE probe tip T13M TEOAE probe tip R13M TE+DPOAE probe tip DPOAE foam probe tips - large TEOAE foam probe tips - small TEOAE foam probe tips - large BGD Body & Lid for UGD and SGD Probes BGS Body & Lid for UGS, ECP and SGS Probes DPOAE Probe Couplers Echoport ILO288 USB-II Otoacoustic Emission Instrument DPOAE + TEOAE Echoport ILO292 USB-I Otoacoustic Emission Instrument DPOAE + TEOAE Echoport ILO292 USB-II Otoacoustic Emission Instrument DPOAE + TEOAE UGD Probe UGS Probe DPOAE foam probe tips - small R4.8S TE+DPOAE probe tip R5.8B TE+DPOAE probe tip R6.8B TE+DPOAE probe tip R7M TE+DPOAE probe tip R8M TE+DPOAE probe tip T3E TEOAE probe tip T4.5C TEOAE probe tip T5.5B TEOAE probe tip T5C TEOAE probe tip T6.5B TEOAE probe tip T7M TEOAE probe tip T8M TEOAE probe tip T9M TEOAE probe tip TEOAE Probe Couplers
- Model Identifier(s)
- A90-07-2-0 A90-10-2-0 A90-11-2-0 A90-18-2-0 A90-19-2-0 A90-27-1-0 A90-28-1-0 A90-29-1-0 BGD BGS DPC-10 ILO288 USB-II ILO292 USB-I ILO292 USB-II PR-UGD PR-UGS T-R100S T-R4.8S T-R5.8B T-R6.8B T-R7M T-R8M T-T3E T-T4.5C T-T5.5B T-T5C T-T6.5B T-T7M T-T8M T-T9M TPC-10
About this record
Access comprehensive regulatory information for Otodynamics Echoport USB Otoacoustic Emission (OAE) Instrument in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501211 and owned by Otodynamics Ltd. The device was registered on February 12, 2018.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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