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Ambu Open Cuff Silicone Face Mask - HSA Registration DE0500233

Access comprehensive regulatory information for Ambu Open Cuff Silicone Face Mask in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500233 and owned by Ambu A/S. The device was registered on July 02, 2014.

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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CLASS B
DE0500233
Ambu Open Cuff Silicone Face Mask
HSA Registration Number: DE0500233
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Product Description

The Ambu® Open Cuff Face Mask is a reusable face mask intended for use with manual resuscitators, automatic resuscitators and ventilators.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration Information
Registration Number
DE0500233
Registration Date
July 02, 2014
Retention Due Date
July 01, 2025
Product Owner
Short Name
Ambu A/S
Address
Baltorpbakken 13, DK-2750 Ballerup., Denmark, DENMARK
Registrant
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552 211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model Information
Model Name(s)
Ambu® Open Cuff Silicone Face Mask Ambu® Open Cuff Silicone Face Mask Ambu® Open Cuff Silicone Face Mask Ambu® Open Cuff Silicone Face Mask Ambu® Open Cuff Silicone Face Mask Ambu® Open Cuff Silicone Face Mask
Model Identifier(s)
000 251 001 000 251 002 000 251 003 000 251 004 000 251 005 000 251 006