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Singapore HSA registration DE0012479

GN Otometrics MADSEN Itera II Clinical Diagnostic Audiometer

Singapore flagSingapore·CLASS B·GN Otometrics A/S·Registered March 01, 2013
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration information
Registration Number
DE0012479
Registration Date
March 01, 2013
Retention Due Date
February 28, 2026
Product description
Itera II is intended for diagnostic and clinical use by audiologists and other health care professionals in testing the hearing of their patients. The OTOsuite Audiometry Module is intended for screening and diagnostic use by audiologists and other health care professionals in testing the hearing of their patients.
Product Owner
Name
GN Otometrics A/S
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)
Test earmould no. 4 Test earmould no. 6 Monitoring Headset w/boom mic. CD Player Serial cable CD Power cable/adaptor Power cord, US (UL approved) Power cord, CH Isolation Transformer Phono CD cable w/GND Audiogram pad, size A5 Service Manual, INT Roller pen, blue Roller pen, red User Manual, CN User Manual, DE User Manual, EN User Manual, ES User Manual, FR User Manual, IT PA 210, 2-ch. Power Amplifier, INT Free-Field Loudspeaker 2 pcs. MADSEN Itera II MADSEN Itera II with gooseneck Patient Signal Switch, Grey Carrying case for Itera II High Frequency SW module excluding headset HIS/MHA sw module SISI sw module Fowler/ABLB sw module Stenger sw module OTOsuite Application Software CD OTOsuite Audiometry License OTOsuite Audiometry up-grade license Wall mounting kit for PA 210 Accessory kit, US E-A-R tone, Tube Nipples (10 pcs) Stereo microphone kit Cable, Jack/Jack, stereo Power cable, Schuko Power cord, DK Cable for CD connection USB to serial converter cable Power cord, UK DIN to Jack/male adapter DIN to Jack/Female adapter Power cord, AUS Power cord, CN Microphone, w. table stand ''jack'' Headset ME70, w. 12 kHz matched TDH39 phones, jack Boneconductor w/headband and cable Headset, Holmco Headset, HDA200 (High Frequency) E-A-RTONE 3A insert phone, Stereo Headset, HB-7, 12kHz matched TDH 39 phones, jack TO/TB Sound Tube Eartip, Earlink 3A, standard (bag of 50 pcs) Eartip, Earlink 3B, small (bag of 50 pcs) Eartip, Earlink 3C, jumbo (bag of 24 pcs) Cables for FF loudspeakers, 3 M
Model Identifier(s)
1-25-004 1-25-006 2-18-04000 2-24-024 30-5600600 40D5617500 7-08-017 7-08-027 7-08-09100 7-08-10700 7-16-024 7-26-66500 7-29-006 7-29-007 7-50-08600-CN 7-50-08600-DE 7-50-08600-EN 7-50-08600-ES 7-50-08600-FR 7-50-08600-IT 8-02-24002 8-02-450 8-04-02200 8-04-02204 8-31-200 8-35-15600 8-49-65100 8-49-65101 8-49-65102 8-49-65103 8-49-65104 8-49-75800 8-49-75803 8-49-75804 8-61-430 8-62-35600 8-68-32000 8-69-25800 8-70-820 8-71-240 8-71-290 8-71-500 8-71-80000 8-71-80200 8-71-80500 8-71-80600 8-71-82700 8-71-86400 8-72-240 8-75-260 8-75-490 8-75-620 8-75-700 8-75-720 8-75-780 8-75-81702 80A4820900 80A4821000 80A4821100 80B5615001
About this record

Access comprehensive regulatory information for GN Otometrics MADSEN Itera II Clinical Diagnostic 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 DE0012479 and owned by GN Otometrics A/S. The device was registered on March 01, 2013.

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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