Singapore HSA registration DE0507364
Teleflex LMA Unique™ (Silicone Cuff) Cuff Pilot Laryngeal Mask Airway
Singapore·CLASS B·Teleflex Medical·Registered October 11, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Anaesthesiology
Registration information
- Registration Number
- DE0507364
- Registration Date
- October 11, 2022
- Change Notification Approval Date
- September 17, 2024
- Retention Due Date
- October 10, 2025
Product description
The LMA® Unique™ (Silicone Cuff) Cuff Pilot™ is intended to be used to facilitate oxygenation and ventilation. The LMA® Unique™ (Silicone Cuff) Cuff Pilot™ is indicated for use in achieving and maintaining control of, the patient’s airway during routine anesthetic procedures, in fasted patients, using either spontaneous or Positive Pressure Ventilation (PPV). It is also indicated for use as a rescue airway device in Cardiopulmonary Resuscitation (CPR) procedures, in which supraglottic airways have traditionally been used as highlighted in numerous international airway management guidelines. Similarly, it is also indicated as a “rescue airway device” in known, or unexpected difficult airway situations.
Product Owner
- Name
- Teleflex Medical
- Short Name
- Teleflex Medical
- Address
- IDA Business and Technology Park, Dublin Road, Athlone, Co. Westmeath, IRELAND
Registrant
- Address
- 83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Importer
- Address
- 83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Model information
- Model Name(s)
- LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 1 LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 1.5 LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 2 LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 2.5 LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 3 LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 4 LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 5 LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 6
- Model Identifier(s)
- 105200-000010 105200-000015 105200-000020 105200-000025 105200-000030 105200-000040 105200-000050 105200-000060
About this record
Access comprehensive regulatory information for Teleflex LMA Unique™ (Silicone Cuff) Cuff Pilot Laryngeal Mask Airway in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507364 and owned by Teleflex Medical. The device was registered on October 11, 2022.
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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