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Singapore HSA registration DE0505106

Sturdy Silicon Manual Resuscitators

Singapore flagSingapore·CLASS B·Sturdy Industrial Co., Ltd.·Registered November 04, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0505106
Registration Date
November 04, 2020
Retention Due Date
November 03, 2025
Product description
The manual resuscitator is intended for manually-powered controlled or assisted ventilation with ambient air with or without added oxygen. This device is intended for use by qualified medical and emergency personnel trained in pulmonary ventilation and advanced cardiac life support techniques.
Product Owner
Name
Sturdy Industrial Co., Ltd.
Short Name
Sturdy Industrial Co., Ltd.
Address
No. 168, Sec. 1, Zhongxing Road., WuGu District, New Taipei City, 24872 Taiwan, TAIWAN
Registrant
Name
WALEN TEC ASIA PTE LTD
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #04-02, SINGAPORE 408734
Importer
Name
WALEN TEC ASIA PTE LTD
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #04-02, SINGAPORE 408734
Model information
Model Name(s)
Silicone mask (Autoclavable) SM-030 Silicone mask (Autoclavable) SM-031 Silicone mask (Autoclavable) SM-032 Silicone mask (Autoclavable) SM-033 Silicone mask (Autoclavable) SM-034 Silicone mask (Autoclavable) SM-035 Sturdy Oropharyngeal Airway (Non-sterile) Sturdy Oropharyngeal Airway (Non-sterile) Sturdy Oropharyngeal Airway (Non-sterile) Sturdy Oropharyngeal Airway (Non-sterile) Sturdy Oropharyngeal Airway (Non-sterile) Sturdy Oropharyngeal Airway (Non-sterile) Sturdy Oropharyngeal Airway (Non-sterile) Pocket type resuscitation Face Mask Sturdy Resuscitator Kit Silicone Manual Resuscitator (Child)
Model Identifier(s)
HS-8800 HS-8801 HS-8802 HS-8803 HS-8804 HS-8805 SG-005 SG-006 SG-007 SG-008 SG-009 SG-010 SG-011 SP-007 SR-001-B1 SR-002 (-B2)
About this record

Access comprehensive regulatory information for Sturdy Silicon Manual Resuscitators in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505106 and owned by Sturdy Industrial Co., Ltd.. The device was registered on November 04, 2020.

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