Pure Global
Singapore HSA registration DE0509089

Ambu aScope™ 5 Broncho HD

Singapore flagSingapore·CLASS B·Ambu A/S·Registered March 21, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0509089
Registration Date
March 21, 2024
Change Notification Approval Date
April 01, 2025
Retention Due Date
March 20, 2026
Product description
aScope 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. It provides visualization via a compatible Ambu displaying unit, and to allow administration of fluids and passing of endotherapy instruments via its working channel. aScope 5 Broncho Sampler Set enables aspiration and collection of fluid samples.
Product Owner
Name
Ambu A/S
Short Name
Ambu A/S
Address
Baltorpbakken 13, DK-2750 Ballerup., Denmark, DENMARK
Registrant
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model information
Model Name(s)
aScope™ 5 Broncho HD 5.0/2.2 aScope™ 5 Broncho HD 5.0/2.2 Sampler Set aScope™ 5 Broncho HD 5.6/2.8 aScope™ 5 Broncho HD 5.6/2.8 Sampler Set
Model Identifier(s)
621001000 621002000 622001000 622002000
About this record

Access comprehensive regulatory information for Ambu aScope™ 5 Broncho HD in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509089 and owned by Ambu A/S. The device was registered on March 21, 2024.

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