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HSA · registration DE0507364

Teleflex LMA Unique™ (Silicone Cuff) Cuff Pilot Laryngeal Mask Airway

SingaporeAnaesthesiologyClass BTeleflex Medical
Official record identity
Registration number
DE0507364
Model name
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
105200-000010; 105200-000015; 105200-000020; 105200-000025; 105200-000030; 105200-000040; 105200-000050; 105200-000060
Registration date
October 11, 2022
Source update date
September 17, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Anaesthesiology
Published parties
Product owner
Teleflex Medical
Registrant / registration holder
TELEFLEX MEDICAL ASIA PTE. LTD.
Official 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.

Additional source fields
Product owner address
IDA Business and Technology Park, Dublin Road, Athlone, Co. Westmeath, Ireland
Registrant address
83 CLEMENCEAU AVENUE, #05-05-08, UE SQUARE, Singapore 239920
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.