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Flexicare Infant Resuscitation T-Piece Circuit with Adjustable PEEP - HSA Registration DE0504051

Access comprehensive regulatory information for Flexicare Infant Resuscitation T-Piece Circuit with Adjustable PEEP in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504051 and owned by Flexicare Medical Limited. The device was registered on January 22, 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.

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CLASS B
DE0504051
Flexicare Infant Resuscitation T-Piece Circuit with Adjustable PEEP
HSA Registration Number: DE0504051
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Product Description

Infant Resuscitation T-piece Circuits are intended to facilitate delivery of oxygen or blended gases to provide manually controlled ventilation and pulmonary resuscitation to Infants weighing <10kg.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504051
Registration Date
January 22, 2020
Retention Due Date
January 21, 2026
Product Owner
Short Name
Flexicare Medical Limited
Address
Cynon Valley Business Park, Mountain Ash CF45 4ER., UNITED KINGDOM
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model Information
Model Name(s)
Infant Resuscitator T-Piece Circuit 1.8m (70”) with Adjustable PEEP (NF-150GE) Infant Resuscitation Kit. T-Piece Circuit 1.8m (70”) with Anatomical Mask Size 0 (NF-157-0GE) Infant Resuscitation Kit T-Piece Circuit 1.8m (70”) with anatomical Mask Size 1 (NF-157-1GE)
Model Identifier(s)
2109059-001 2109060-001 2109061-001