Singapore HSA registration DE0019104

NATUS Madsen Zodiac Auditory Impedance Tester

Singapore·CLASS B·Natus Medical Denmark ApS·Registered March 28, 2017

Device classification

Device Class: CLASS B
Medical Speciality Area: Ear, Nose & Throat

Registration information

Registration Number: DE0019104
Registration Date: March 28, 2017
Change Notification Approval Date: December 07, 2023
Retention Due Date: March 27, 2026

Product description

MADSEN Zodiac is an auditory impedance tester that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. This devide is also used to measure the acoustic reflex threshold and decay testing as well as Eustachian tube function testing for intact and perforated tympanic membranes.

Product Owner

Name: Natus Medical Denmark ApS
Short Name: Natus Medical Denmark ApS
Address: Hoerskaetten 9, DK-2630 Taastrup, DENMARK

Registrant

Name: ACCESS-2-HEALTHCARE
Address: 42 KIM YAM ROAD, OLEANAS RESIDENCE, #19-02, SINGAPORE 239347

Importer

Name: Surgipro Pte Ltd
Address: 23 WOODLANDS INDUSTRIAL PARK E1, ADMIRALTY INDUSTRIAL PARK, #03-05, SINGAPORE 757741

Model information

Model Name(s): MADSEN Zodiac SA Quick Check with Printer MADSEN Zodiac SA Diagnostic with Printer MADSEN Zodiac SA Clinical with Printer MADSEN Zodiac SA Quick without Printer MADSEN Zodiac SA Diagnostic without Printer MADSEN Zodiac SA Clinical without Printer MADSEN Zodiac Type 1096 SA Quick Check w/ Printer MADSEN Zodiac Type 1096 SA Diagnostic w/ Printer MADSEN Zodiac Type 1096 SA Clinical w/ Printer MADSEN Zodiac Type 1096 SA Quick Check w/ Printer MADSEN Zodiac Type 1096 SA Diagnostic w/ Printer MADSEN Zodiac Type 1096 SA Clinical w/ Printer MADSEN Zodiac Type 1096 SA Diagnostic w/ Printer MADSEN Zodiac Type 1096 SA Clinical w/ Printer MADSEN Zodiac Type 1096 SA Diagnostic w/ Printer MADSEN Zodiac Type 1096 SA Diagnostic w/ Printer MADSEN Zodiac Type 1096 SA Clinical w/ Printer MADSEN Zodiac Type 1096 SA Clinical w/ Printer MADSEN Zodiac Type 1096 SA Diagnostic w/ Printer MADSEN Zodiac Type 1096 SA Clinical w/ Printer MADSEN Zodiac Type 1096 SA Quick Check w/o Printer MADSEN Zodiac Type 1096 SA Diagnostic w/o Printer MADSEN Zodiac Type 1096 SA Clinical w/o Printer MADSEN Zodiac Type 1096 SA Quick Check w/ Printer MADSEN Zodiac Type 1096 SA Diagnostic w/ Printer MADSEN Zodiac Type 1096 SA Clinical w/ Printer MADSEN Zodiac Type 1096 SA Quick Check w/o Printer MADSEN Zodiac Type 1096 SA Diagnostic w/o Printer MADSEN Zodiac Type 1096 SA Clinical w/o Printer MADSEN Zodiac Type 1096 SA Diagnostic w/ Printer MADSEN Zodiac Type 1096 SA Diagnostic w/o Printer MADSEN Zodiac Type 1096 SA Clinical w/ Printer MADSEN Zodiac Type 1096 SA Clinical w/o Printer MADSEN Zodiac Type 1096 SA Diagnostic w/o Printer MADSEN Zodiac Type 1096 SA Diagnostic w/o Printer MADSEN Zodiac Type 1096 SA Clinical w/o Printer 1096 Zodiac SA QC w. printer 1096 Zodiac SA QC w. printer 1096 Zodiac SA QC w. printer 1096 Zodiac SA QC w. printer 1096 Zodiac SA QC w/o printer 1096 Zodiac SA QC w/o printer 1096 Zodiac PC QC 1096 Zodiac PC QC 1096 Zodiac SA Diag. w. printer 1096 Zodiac SA Diag. w. printer 1096 Zodiac SA Diag. w. printer 1096 Zodiac SA Diag. w. printer 1096 Zodiac SA Diag. w. printer 1096 Zodiac SA Diag. w. printer 1096 Zodiac SA Diag. w. printer 1096 Zodiac SA Diag. w/o printer 1096 Zodiac SA Diag. w/o printer 1096 Zodiac SA Diag. w/o printer 1096 Zodiac SA Diag. w/o printer 1096 Zodiac SA Diag. w/o printer 1096 Zodiac SA Diag. w/o printer 1096 Zodiac SA Diag. w/o printer 1096 Zodiac SA Clinical w. printer 1096 Zodiac SA Clinical w. printer 1096 Zodiac SA Clinical w. printer 1096 Zodiac SA Clinical w. printer 1096 Zodiac SA Clinical w. printer 1096 Zodiac SA Clinical w. printer 1096 Zodiac SA Clinical w. printer 1096 Zodiac SA Clinical w/o printer 1096 Zodiac SA Clinical w/o printer 1096 Zodiac SA Clinical w/o printer 1096 Zodiac SA Clinical w/o printer 1096 Zodiac SA Clinical w/o printer 1096 Zodiac PC Diagnostic 1096 Zodiac PC Diagnostic 1096 Zodiac PC Diagnostic 1096 Zodiac PC Diagnostic 1096 Zodiac PC Diagnostic 1096 Zodiac PC Diagnostic 1096 Zodiac PC Clinical 1096 Zodiac PC Clinical 1096 Zodiac PC Clinical 1096 Zodiac PC Clinical 1096 Zodiac Quick Check Probe Gen 2 Kit 1096 Zodiac Diagnostic Probe Gen 2 Kit 1096 Zodiac Quick Check Gen 2 Tube Replacement Kit 1096 Zodiac Diagnostic Gen 2 Tube Replacement Kit 1096 Zodiac Quick Check Gen 2 Tube Cover Kit 1096 Zodiac Diagnostic Gen 2 Tube Cover Kit 1096 Zodiac Gen 2 Probe Tips Kit 1096 Zodiac Gen 2 Device/Wall Mount Kit 1096 Zodiac Gen 2 Shoulder Strap Adapter Kit 1096, SCREENER HOME, DESKTOP OTOsuite PC Software Probe Quick Check Probe diagnostic Classic Probe diagnostic Comfort Eartip Kit in Box Silicone Eartip, 5 mm, blue, tree tip Silicone Eartip, 6 mm, semi gray, tree tip Silicone Eartip, 7 mm, semi red, mushroom Silicone Eartip, 8 mm, semi green, mushroom Silicone Eartip, 9.5 mm, semi blue, mushroom Silicone Eartip, 11 mm, semi gray, mushroom Silicone Eartip, 12.5 mm, semi red, mushroom Silicone Eartip, 14 mm, semi green, mushroom Silicone Eartip, 16 mm, semi blue, mushroom Silicone Eartip, 18 mm, semi gray, mushroom Silicone Eartip, 10 mm, transparent, umbrella Silicone Eartip, 13 mm, transparent, umbrella Silicone Eartip, 16 mm, transparent, umbrella Silicone Eartip, 19 mm, transparent, umbrella Silicone Eartip, 22 mm, transparent, umbrella Eartips, 3-6mm, green (tree tip), pack of 100 Eartips, 6mm, yellow, pack of 100 Eartips, 7mm, red, pack of 100 Eartips, 8mm, blue, pack of 100 Eartips, 9mm, green, pack of 100 Eartips, 10mm, yellow, pack of 100 Eartips, 11mm, red, pack of 100 Eartips, 12mm, blue, pack of 100 Eartips, 13mm, green, pack of 100 Eartips, 14mm, yellow, pack of 100 Eartips, 16mm, red, pack of 100 Eartips, 18.5mm, blue, pack of 100 1096, PROBE TIP TDH-39 Contra Phone Zodiac Insert Phone Foam Eartip, 3A (Standard) Foam Eartip, 3B (Small) Foam Eartip, 3C (Jumbo)
Model Identifier(s): 8-04-16001 8-04-16002 8-04-16003 8-04-16004 8-04-16005 8-04-16006 8-04-16020 8-04-16021 8-04-16022 8-04-16023 8-04-16024 8-04-16025 8-04-16050 8-04-16051 8-04-16054 8-04-16055 8-04-16056 8-04-16057 8-04-16062 8-04-16063 8-04-16064 8-04-16065 8-04-16066 8-04-16070 8-04-16071 8-04-16072 8-04-16073 8-04-16074 8-04-16075 8-04-16078 8-04-16079 8-04-16080 8-04-16081 8-04-16084 8-04-16085 8-04-16086 8-04-16301 8-04-16302 8-04-16303 8-04-16304 8-04-16305 8-04-16306 8-04-16307 8-04-16308 8-04-16309 8-04-16310 8-04-16311 8-04-16312 8-04-16313 8-04-16314 8-04-16316 8-04-16317 8-04-16318 8-04-16319 8-04-16320 8-04-16321 8-04-16322 8-04-16323 8-04-16324 8-04-16325 8-04-16326 8-04-16327 8-04-16329 8-04-16330 8-04-16332 8-04-16333 8-04-16334 8-04-16335 8-04-16336 8-04-16337 8-04-16338 8-04-16339 8-04-16340 8-04-16341 8-04-16342 8-04-16344 8-04-16345 8-04-16346 8-04-16348 8-04-16350 8-35-10001 8-35-10002 8-35-10003 8-35-10004 8-35-10005 8-35-10006 8-35-10007 8-35-10008 8-35-10009 8-35-47200 8-49-75800 8-66-10000 8-66-10100 8-66-10200 8-68-29601 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 8-68-31961 8-68-31962 8-68-31963 8-68-31964 8-68-31965 8-68-31966 8-68-31967 8-68-31968 8-68-31969 8-68-31970 8-68-31971 8-68-31972 8-68-34400 8-75-85300 8-75-85400 80A4820900 80A4821000 80A4821100

About this record

Access comprehensive regulatory information for NATUS Madsen Zodiac Auditory Impedance Tester in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019104 and owned by Natus Medical Denmark ApS. The device was registered on March 28, 2017.

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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