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Teleflex Medical Gibeck ISO-GARD Bacterial/Viral Filter - HSA Registration DE0016784

Access comprehensive regulatory information for Teleflex Medical Gibeck ISO-GARD Bacterial/Viral Filter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016784 and owned by Teleflex Medical Sdn. Bhd.. The device was registered on February 02, 2015.

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
DE0016784
Teleflex Medical Gibeck ISO-GARD Bacterial/Viral Filter
HSA Registration Number: DE0016784
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Product Description

Bacterial/viral filters for use in breathing systems for the protection of the patient. ISO-Gard HEPA Light Filter/HME can be used as a combined bacterial/viral filter and Heat & Moisture Exchanger (HME).

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00102
HS Code
90200000
Registration Information
Registration Number
DE0016784
Registration Date
February 02, 2015
Retention Due Date
February 01, 2026
Product Owner
Short Name
Teleflex Medical Sdn. Bhd.
Address
Lot PT 2577, Jalan Perusahaan 4, 34600 Kamunting Perak, MALAYSIA
Registrant
Address
83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Importer
Address
1 KALLANG JUNCTION, #05-01, SINGAPORE 339263 83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Model Information
Model Name(s)
ISO-GARD HEPA LIGHT PORT ISO-GARD HEPA LIGHT ISO-GARD HEPA LIGHT ISO-GARD HEPA SMALL A ISO-GARD HEPA SMALL S
Model Identifier(s)
28002 28012 28022 28052 28062