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Singapore HSA registration DE0509722

Ambu® aScope™ 5 Broncho (Small Sizes)

Singapore flagSingapore·CLASS B·Ambu A/S·Registered September 03, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration information
Registration Number
DE0509722
Registration Date
September 03, 2024
Retention Due Date
September 02, 2025
Product description
aScope 5 Broncho are sterile, single-use flexible bronchoscopes designed to conduct endoscopic procedures and examination of the airways and tracheobronchial tree. The aScope 5 Broncho endoscopes feature an integrated camera module with built-in dual LED (Light Emitting Diodes) illumination and are intended to provide visualization via a compatible Ambu® displaying unit.
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 BronchoSampler™ 60 SC, sample container spares aScope™ 5 Broncho 4.2/2.2 aScope™ 5 Broncho 4.2/2.2 Sampler Set aScope™ 5 Broncho 2.7/1.2
Model Identifier(s)
480500000 620001000 620002000 624001000
About this record

Access comprehensive regulatory information for Ambu® aScope™ 5 Broncho (Small Sizes) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509722 and owned by Ambu A/S. The device was registered on September 03, 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