Singapore HSA registration DE0500043
OTOMETRICS Madsen Xeta Audiometer
Singapore·CLASS B·GN Otometrics A/S·Registered December 06, 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
- DE0500043
- Registration Date
- December 06, 2012
- Retention Due Date
- December 05, 2025
Product description
The Madsen Xeta is intended for screening and diagnostic use by audiologists and other health care professionals in testing the hearing of their patients.
Product Owner
- Short Name
- GN Otometrics
- Address
- Hoerskaetten 9, Taastrup 2630, DENMARK
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)
- Serial cable Power cord, US (UL approved) Power cord, CH Isolation Transformer Audiogram pad, size A5 Roller pen, blue Roller pen, red User Manual, Print, CN User Manual, Print, DE User Manual, Print, EN User Manual, Print, ES User Manual, Print, FR User Manual, Print, IT User Manual, Print, RU MADSEN Xeta Carrying bag SISI sw module Fowler/ABLB sw module Stenger sw module OTOsuite Application Software CD OTOsuite Audiometry up-grade license Power cable, Schuko Power cord, DK USB to serial converter cable Power cord, UK Power cord, AUS Power cord, CN Headset, HB-7, 8kHz matched TDH39 phones, jack Boneconductor w/headband and cable Headset, Holmco E-A-RTONE 3A insert phone, Stereo E-A-RTONE 3A insert phone, Mono Headset, ME70, w. 8 kHz Eartip, Earlink 3A, standard (bag of 50 pcs) Eartip, Earlink 3B, small (bag of 50 pcs) Eartip, Earlink 3C, jumbo (bag of 24 pcs) Patient Signal, switch, grey
- Model Identifier(s)
- 30-5600600 7-08-017 7-08-027 7-08-09100 7-16-024 7-29-006 7-29-007 7-50-08700-CN 7-50-08700-DE 7-50-08700-EN 7-50-08700-ES 7-50-08700-FR 7-50-08700-IT 7-50-08700-RU 8-04-12200 8-35-14300 8-49-65102 8-49-65103 8-49-65104 8-49-75800 8-49-75804 8-71-240 8-71-290 8-71-80000 8-71-80200 8-71-82700 8-71-86400 8-75-430 8-75-490 8-75-620 8-75-720 8-75-730 8-75-770 80A4820900 80A4821000 80A4821100 80B4877300
About this record
Access comprehensive regulatory information for OTOMETRICS Madsen Xeta Audiometer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500043 and owned by GN Otometrics A/S. The device was registered on December 06, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B