Singapore HSA registration DE0500008

NATUS Madsen Astera Audiometer

Singapore·CLASS B·Natus Medical Denmark ApS·Registered October 05, 2012

Device classification

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

Registration information

Registration Number: DE0500008
Registration Date: October 05, 2012
Change Notification Approval Date: August 15, 2024
Retention Due Date: October 04, 2025

Product description

The MADSEN Astera is intended for diagnostic and clinical use by audiologists and other health care professionals in testing the hearing of their patients

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): BC-2 Bone Conductor with Headband BC-2 Receiver ACP Wrist Support Cable Cover Power Supply, 24VDC, 80W Power cord, US (UL approved) Power cord, CH Conera, User Manual, CN Astera, User Manual, DE Astera, User Manual, EN Astera, User Manual, ES Astera, User Manual, FR Astera, User Manual, IT BC-1-HEADBAND-MON/SW Free-Field Loudspeaker 2 pcs. MADSEN Astera without ACP MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 1066 Madsen Astera 2 1066 Madsen Astera 2 1066 Madsen Astera 2 1066 Madsen Astera 2 1066 Madsen Astera 2 MADSEN Astera with ACP MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 MADSEN Astera2 Type 1066 1066 Madsen Astera 2 1066 Madsen Astera 2 1066 Madsen Astera 2 1066 Madsen Astera 2 1066 Madsen Astera 2 1066 Madsen Astera 2 1066 Madsen Astera 2 Patient Signal, Red Patient Signal, Blue Patient Signal Switch, Grey OTOsuite Application Software CD Speech Material CD, US 1066, 1081, CALIB SW 3.00.03 OTOsuite - QUASAR Interface ver. 1.00 Speech Material CD, UK Speech Material DVD, DE Speech Material DVD, FR Speech Material CD, ES Speech Material DVD, IT Speech Material CD, AUS Speech Material CD, CN Speech Material DVD, SE Speech Material CD, DK Speech Material CD, NO Speech Material CD, NZ Speech Material CD, NL Speech Material CD, CN TON Speech Material CD, CN 301 AB/OTOsuite Aud Control Panel Wall mounting Kit ACP upgrade w. wrist support, EN ACP upgrade w. wrist support ACP upgrade w. wrist support, DE Power cable, Schuko Power cord, DK Cable, USB type A-B, 3 meters Cable, USB type A-B, 2 meters Power cord, UK Power cord, AUS Power cord, CN Connection Cable, Male/Male Connection Cable, Male/Female Monitor Speaker Cable Operator Headset Cable, Mini Jack Microphone w/table stand ''Jack'' Headset ME70, w. 12 kHz matched TDH39 phones, jack Headset, HB-7, 8kHz matched TDH39 phones, jack Headset, HB-8, 8kHz matched TDH39 phones, jack Boneconductor w/headband and cable 1099, BC-1 BONE W-HEADBAND Monitor Headset w/cable Headset, HDA200 (High Frequency) E-A-RTONE 3A insert phone, Stereo Headset, HB-7, 12kHz matched TDH 39 phones, jack Monitor Speaker Kit Insert Earphone Stereo 10 ohm Assistent Headset w/volume Control TO/TB Sound Tube Headset, HDA 300 (High Frequency) Headset, HDA 300 (High Frequency) Eartip, Earlink 3A, standard Eartip, Earlink 3B, small Eartip, Earlink 3C, jumbo
Model Identifier(s): 041545 041546 1-10-64700 1-12-56200 5-01-10100 7-08-017 7-08-027 7-50-07800-CN 7-50-07800-DE 7-50-07800-EN 7-50-07800-ES 7-50-07800-FR 7-50-07800-IT 77734695 8-02-450 8-04-12100 8-04-12116 8-04-12117 8-04-12118 8-04-12119 8-04-12120 8-04-12121 8-04-12122 8-04-12416 8-04-12417 8-04-12418 8-04-12419 8-04-12420 8-04-13100 8-04-13104 8-04-13120 8-04-13121 8-04-13122 8-04-13123 8-04-13124 8-04-13125 8-04-13126 8-04-13127 8-04-13128 8-04-13404 8-04-13420 8-04-13421 8-04-13422 8-04-13423 8-04-13424 8-04-13425 8-31-190 8-31-19002 8-31-200 8-49-75800 8-49-82400 8-49-82500 8-49-88000 8-49-88200 8-49-88300 8-49-88400 8-49-88500 8-49-88600 8-49-89100 8-49-89200 8-49-89300 8-49-89400 8-49-89500 8-49-89600 8-49-89700 8-49-90400 8-49-90500 8-49-90600 8-61-97300 8-69-40800 8-69-40802 8-69-40803 8-71-240 8-71-290 8-71-79100 8-71-79200 8-71-80200 8-71-82700 8-71-86400 8-71-86800 8-71-86900 8-71-87500 8-71-87700 8-72-26610 8-75-260 8-75-430 8-75-435 8-75-490 8-75-50000 8-75-69003 8-75-700 8-75-720 8-75-780 8-75-80601 8-75-81200 8-75-81400 8-75-81702 8-75-82600 8-75-82601 80A4820900 80A4821000 80A4821100

About this record

Access comprehensive regulatory information for NATUS Madsen Astera 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 DE0500008 and owned by Natus Medical Denmark ApS. The device was registered on October 05, 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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