Singapore HSA registration DE0500095

GNO Madsen OTOflex 100

Singapore·CLASS B·GN Otometrics A/S·Registered May 06, 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: DE0500095
Registration Date: May 06, 2013
Retention Due Date: May 05, 2026

Product description

OTOflex 100 is an audiodiagnostic device intended for clinical, diagnostic and screening tympanometry and reflex measurements performed by audiologists, ENTs and other health care professionals. It is designed for use on infants, children and adults.

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): Bluetooth Parallel port, US Bluetooth USB printer adapter EU Power cord, EU (straight) Power cord, UK (straight) Power cord, US (straight) Power cord, AUS (straight) CD Mains cord HO5VV, CN Power cord, EU (angled) Power cord, UK (angled) Power cord US, (angled) Power cord, AUS (angled) Power cord, CN (angled) OTOflex 100 Ref. Manual, INT ODS Reference Manual, INT ODS Install Manual, UK ODS Install Manual, DE ODS Install Manual, FR ODS Install Manual, ES ODS Install Manual, IT Quick Guide, UK User Manual, CN User Manual, DE User Manual, EN User Manual, ES User Manual, FR User Manual, IT MADSEN Otoflex 100 Diagnostic MADSEN Otoflex 100 Quick-Check Charger/cradle, tabletop foot, Kit incl. straight power cable (8-35-207xx) Device cap Carrying case, OTOflex 100 Wallmount kit for charger/cradle incl. angled power cable Quick Check to Diagnostic, OTOflex 100(License only, no HW) Remote control from PC, upgrade OTOsuite DVD OTOair Bluetooth Dongle Shoulder harness incl. cable clips Quick Check to Diagnostic Complete, (SW and HW) Infant eartips (50 pcs.) 3 mm, grey (tree tip) Infant eartips (50 pcs.) 4mm, green (tree tip) Infant eartips (50 pcs.) 5 mm, blue (tree tip) Regular eartips (50 pcs.) 6 mm, semi grey Regular eartips (50 pcs.) 7 mm, semi red Regular eartips (50 pcs.) 8 mm, semi green Regular eartips (50 pcs.) 9,5 mm, semi blue Regular eartips (50 pcs.) 11 mm, semi grey Regular eartips (50 pcs.) 12,5 mm, semi red Regular eartips (50 pcs.) 14mm, semi green Regular eartips (50 pcs.) 16 mm, semi blue Regular eartips (50 pcs.) 18 mm, semi grey Screening eartips (50 pcs.) 10 mm, transparent Screening eartips (50 pcs.) 13 mm, transparent Screening eartips (50 pcs.) 16 mm, transparent Screening eartips (50 pcs.) 19 mm, transparent Screening eartips (50 pcs.) 22 mm, transparent E-A-R tone, Tube Nipples (10 pcs) Immittance probe 180 cm. 180 cm immittance probe complete, incl. 1 Wax filter kit, 1 cleaning kit Set of probe tips (2 pcs.) and locking nuts (2 pcs.) Probe Tip Kit, (1 pcs.) Cleaning kit for immittance probe tip (5 wires + 1 brush) Wax filter kit (5 filters + 1 tool) Handy eartip box (empty) Eartip Box, Large Ni-MH rechargeable battery, 1 pcs.1800 mAh - AA size -NiMH EARtone-3A intelligent contra insert phone (1 pcs.) incl. eartip start selection Eartip, Earlink 3A, standard (bag of 50 pcs) Eartip, Earlink 3B, small (bag of 50 pcs) Eartip, Earlink 3C, jumbo (bag of 24 pcs)
Model Identifier(s): 2-25-08200 2-25-08201 7-08-07500 7-08-07501 7-08-07502 7-08-07503 7-08-07504 7-08-07600 7-08-07601 7-08-07602 7-08-07603 7-08-07604 7-50-00000 7-50-00200 7-50-03400 7-50-03401 7-50-03402 7-50-03403 7-50-03404 7-50-04100 7-50-08800-CN 7-50-08800-DE 7-50-08800-EN 7-50-08800-ES 7-50-08800-FR 7-50-08800-IT 8-04-04900 8-04-04901 8-35-18101 8-35-18600 8-35-20601 8-35-20700 8-49-68151 8-49-68153 8-49-75800 8-62-41503 8-66-22100 8-66-99800 8-68-31500 8-68-31501 8-68-31502 8-68-31503 8-68-31504 8-68-31505 8-68-31506 8-68-31507 8-68-31512 8-68-31513 8-68-31514 8-68-31515 8-68-31600 8-68-31601 8-68-31602 8-68-31603 8-68-31604 8-68-32000 8-69-27501 8-69-27900 8-69-27901 8-69-28000 8-69-28100 8-69-28400 8-69-28500 8-73-02100 8-75-73050 80A4820900 80A4821000 80A4821100

About this record

Access comprehensive regulatory information for GNO Madsen OTOflex 100 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500095 and owned by GN Otometrics A/S. The device was registered on May 06, 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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