Singapore HSA registration DE0011793
Otodynamics OTOPORT Otoacoustic Emission (OAE) System
Singapore·CLASS B·Otodynamics Ltd·Registered December 11, 2012Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90181900
Registration information
- Registration Number
- DE0011793
- Registration Date
- December 11, 2012
- Retention Due Date
- December 10, 2025
Product description
The Otoport can screen for cochlear function using either Transient Evoked or Distortion Product Otoacoustic Emissions (TEOAE or DPOAE). It uses state-of-the-art technology and high performance signal analysis to provide robust indications of cochlear function and high immunity to extraneouse noise.
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)
- Otoport Charger Otoport Docking Station Otoport Mini Printer, including Charger, Printer Cable and Paper Otoport Mini Printer Charger Otoport Mini Printer Self-Adhesive Paper Otoport Mini Printer Standard Paper Otoport Mini Printer Cable Otoport Download Cable Otoport Infection Control Sleeve Otoport Grip Strip Otoport Fabric Carry Case (with printer compartment) Otoport Fabric Carry Case (standard) Otoport Charging Cradle V6 Advanced Data Management and Analysis Software EZ-Screen Patient/Data Management Software TPC Probe Couplers - per 100 TPC Probe Couplers - per 10 DPC Probe Couplers - per 100 DPC Probe Couplers - per 10 BNS Body & Lid BGS Body & Lid BND Body & Lid BGD Body & Lid 1cc Test Cavity UGS TEOAE General Purpose Probe UGD TE + DPOAE General Purpose Probe Probe Pouch Probe Cable Clip T3E TEOAE Tips T4.5C TEOAE Tips T5.5B TEOAE Tips T6.5B TEOAE Tips T8M TEOAE Tips T9M TEOAE Tips T11M TEOAE Tips R4.8S TE+DPOAE Tips R8M TE+DPOAE Tips R9M TE+DPOAE Tips R11M TE+DPOAE Tips R9.5F TE+DPOAE Tips R5.8B TE+DPOAE Tips R6.8B TE+DPOAE Tips T13M TEOAE Tips R13M TE+DPOAE Tips T5C TEOAE Tips TEOAE Sample Box TE+DPOAE Sample Box DPOAE Sample Box T7M TEOAE Tips R7M TE+DPOAE Tips FOAM Small DP Tips FOAM Large DP Tips FOAM Small TE Tips FOAM Large TE Tips Additional compact wired Otoport charger Otoport Barcode Scanner option Otoport Wireless module Barcode Scanning Otoport Otoport Otoport Otoport Otoport Otoport Otoport Otoport Otoport Integral ID Chip Reader (RFID) Otoport RFID Scanner option Replace charging cradle with compact wired charger Replace wireless with wired printer in Wireless Printer Package V6 Version upgrade
- Model Identifier(s)
- A15-06-0-0 A15-09-0-0 A15-10-0-0 A15-10-1-0 A15-10-3-0 A15-10-3-1 A15-11-0-0 A15-13-0-0 A15-16-0-0 A15-17-0-0 A15-19-0-0 A15-19-1-0 A15-22-0-0 A70-05-0-1 A70-07-0-1 A80-11-1-0 A80-11-1-1 A80-11-2-0 A80-11-2-1 A80-12-1-0 A80-12-2-0 A80-12-3-0 A80-12-4-0 A80-14-1-0 A80-15-1-0 A80-16-1-0 A80-17-1-0 A80-18-1-0 A90-01-2-0 A90-02-2-0 A90-03-2-0 A90-04-2-0 A90-05-2-0 A90-06-2-0 A90-07-2-0 A90-08-2-0 A90-09-2-0 A90-10-2-0 A90-11-2-0 A90-14-1-0 A90-16-2-0 A90-17-2-0 A90-18-2-0 A90-19-2-0 A90-20-2-0 A90-21-1-0 A90-22-1-0 A90-23-1-0 A90-24-2-0 A90-25-2-0 A90-26-1-0 A90-27-1-0 A90-28-1-0 A90-29-1-0 AWC BAR-PS BT-PS Barcode Otoport Advance Otoport Advance (hi-resolution) Otoport DP + TE Otoport DP + TE (hi-resolution) Otoport Lite DP Otoport Lite DP (hi-resolution) Otoport Lite TE Otoport Lite TE (hi-resolution) Otoport Screener RFID RFID-PS RWC RWP V6-UG
About this record
Access comprehensive regulatory information for Otodynamics OTOPORT Otoacoustic Emission (OAE) System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011793 and owned by Otodynamics Ltd. The device was registered on December 11, 2012.
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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