Singapore HSA registration DE0506244

Natus AURICAL AUD

Singapore·CLASS B·Natus Medical Denmark ApS·Registered October 01, 2021

Device classification

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

Registration information

Registration Number: DE0506244
Registration Date: October 01, 2021
Change Notification Approval Date: May 29, 2024
Retention Due Date: September 30, 2025

Product description

Intended for diagnostic and clinical audiometric testing, hearing instrument fitting and present audio signals

Product Owner

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

Registrant

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

Importer

Name: GN HEARING PTE. LTD. METRO HEALTH TECHNOLOGIES SONOVA SINGAPORE PTE. LTD. Surgipro Pte Ltd
Address: 67 UBI CRESCENT, TECHNIQUES CENTRE, #04-09, SINGAPORE 408560 16 SHAW ROAD, KIN BUILDING, #01-04, SINGAPORE 367954 21 MEDIA CIRCLE, INFINITE STUDIOS, #07-01/04, SINGAPORE 138562 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 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 Aurical Aud - Type 1081 Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 Aurical Aud - Type 1081 Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 Aurical Aud - Type 1081 Aurical Aud - Type 1081 Aurical Aud - Type 1081 Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 Aurical Aud - Type 1081 Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 with built-in HI-PRO 2 Aurical Aud - Type 1081 with built-in HI-PRO 2 1081 Aurical Aud with HI-PRO 2 Aurical Aud - Type 1081 1081 Aurical Aud 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud w/o HI-PRO 2 1081 Aurical Aud w/o HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud w/o HI-PRO 2 1081 Aurical Aud w/o HI-PRO 2 1081 Aurical Aud w/o HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud w/o HI-PRO 2 1081 Aurical Aud with and w/o HI-PRO 2 1081 Aurical Aud with and w/o HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud w/o HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud w/o HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud w/o HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud w/o HI-PRO 2 1081 Aurical Aud w/o HI-PRO 2 1081 Aurical Aud with HI-PRO 2 1081 Aurical Aud with HI-PRO 2 Otosuite® PC Software v. 4.89 1081 Aurical Loudspeaker Headset ME70 (12kHz) matched TDH39 phones (Jack) Headset, HB-7, 12kHz matched TDH39 phones, Jack Headset, HB-8, 12kHz matched TDH39 phones, Jack Earphone 10 Ohm Foam Eartip, 3A (Standard) Foam Eartip, 3B (Small) Foam Eartip, 3C (Jumbo)
Model Identifier(s): 41545 41546 8-04-14538 8-04-14539 8-04-14550 8-04-14551 8-04-14552 8-04-14553 8-04-14554 8-04-14555 8-04-14556 8-04-14557 8-04-14558 8-04-14570 8-04-14571 8-04-14572 8-04-14573 8-04-14574 8-04-14575 8-04-14576 8-04-14577 8-04-14578 8-04-14579 8-04-14580 8-04-14581 8-04-14582 8-04-14583 8-04-14584 8-04-14585 8-04-14586 8-04-14587 8-04-14588 8-04-14589 8-04-14590 8-04-14593 8-04-14594 8-04-14595 8-04-14650 8-04-14651 8-04-14652 8-04-14653 8-04-14654 8-04-14655 8-04-14656 8-04-14657 8-04-14658 8-04-14663 8-04-14664 8-04-14666 8-04-14670 8-04-14671 8-04-14672 8-04-14673 8-04-14674 8-04-14675 8-04-14676 8-04-14677 8-04-14678 8-04-14679 8-04-14680 8-04-14681 8-04-14682 8-04-14688 8-04-14689 8-49-75800 8-62-45200 8-75-260 8-75-780 8-75-790 8-75-81200 80A4820900 80A4821000 80A4821100

About this record

Access comprehensive regulatory information for Natus AURICAL AUD in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506244 and owned by Natus Medical Denmark ApS. The device was registered on October 01, 2021.

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