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Galemed Respiratory Therapy Device - HSA Registration DE0506719

Access comprehensive regulatory information for Galemed Respiratory Therapy Device in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506719 and owned by GaleMed Corporation. The device was registered on March 13, 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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CLASS B
DE0506719
Galemed Respiratory Therapy Device
HSA Registration Number: DE0506719
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Product Description

The Galemed Respiratory Therapy Device is intended to provide a pathway that convey oxygen, anesthesia or other medical fresh gases to the patient. The Galemed Respiratory Therapy Device are indicated for patients who requiring mechanical ventilation, whether for spontaneous breathing or ventilator/support from anaesthesia machine.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0506719
Registration Date
March 13, 2022
Retention Due Date
March 12, 2026
Product Owner
Short Name
GaleMed Corporation
Address
87 Li-gong 2nd Road, Wu-Jia, I-Lan, Taiwan 268, TAIWAN
Registrant
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Importer
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Model Information
Model Name(s)
Gas Sampling Line, 300cm, 4M MDI Adaptor, 22F, 22M MDI Adaptor, 15F, 15M Auto Chamber, Adult Auto Chamber, Infant EVA Corrugate Tube, 22F, 180cm EVA Smoothbore Tube, 22F, 45cm EVA Smoothbore Tube, 22F, 60cm EVA Smoothbore Tube, 22F, 120cm EVA Smoothbore Tube, 22F, 180cm EVA Smoothbore Tube, 22F, 100cm EVA Smoothbore Tube, 22F, 150cm HME, 22F/15M, 22/15 mm HMEF w/Luer, 22F/15M, 22/15 mm Filter, 22F/15M, 22M/15F Filter, HEPA w/luer, 22F/15M, 22/15 mm Hydrophobic Filter, 7.6M w/Luer Filter, 22F/15M, 22M/15Fw/Luer Hydrophobic Filter, 4F, 4M NIV Mask, L NIV Mask, L w/Headgear NIV Mask, M NIV Mask, M w/Headgear NIV Mask, S EVA Circuit, Adult, 120 cm w/2WT EVA Circuit, Child, 120 cm w/2WT EVA Circuit, Infant, 120 cm w/2WT HW2 Circuit, Adult w/Chamber HW2 Circuit, Adult Filter, 22F, 22/15 mm Elbow with Cap Elbow without Cap EVA Catheter mount, 15 cm ,22/15 mm, 15M EVA Catheter Mount, 15 cm, 22F EVA Corrugate Tube, 22F, 100cm EVA Corrugate Tube, 22F, 150cm EVA Corrugate Tube, 15F, 15cm EVA Corrugate Tube, 22F, 15cm LDS2 Catheter Mount, L15F, 22/15 LDS2 Catheter Mount, L15F, 22F LDS1 Catheter Mount, SL15F, 15M LDS1 Catheter Mount, SL15F, 22/15 mm LDS1 Catheter Mount, SL15F, 22F Filter 22F/15M w/Luer Filter, 22F/15M, 22/15 mm HW1 Circuit, Infant w/WT HW1 Circuit, Infant for DR HW1 Circuit, Infant for SLE HW1 Circuit, Infant w/WT, Chamber HW1 Circuit, Infant w/Chamber for DR HW1 Circuit, Infant w/Chamber for SLE HW1 Circuit, Infant w/Chamber, SLE2000 HW2 Circuit, Infant HW2 Circuit, Infant w/Chamber HW1 Circuit, Adult w/WT HW1 Circuit, Adult w/WT, Chamber HW2 Circuit, Adult HW2 Circuit, Adult w/Chamber nHME, 15F, 15M HMEF, 22F/15M, 22/15 mm HMEF w/Luer, 22F/15M, 22/15 mm SL NIV Mask, L SL NIV Mask, M SL NIV Mask, S SL NIV Mask w Port, L SL NIV Mask w Port, M SL NIV Mask w Port, S
Model Identifier(s)
30002 30341 30342 3426 3431 38002 38014 38015 38017 38051 38052 38053 39009 39012 39013 39014 39015 39016 39020 5437 5437-N01 5438 5438-N01 5439 6702 6703 6704 6755 6757 70015 72015 72214 77127 77131 77802 77803 77811 77816 7CBD22 7CBD23 7CCD21 7CCD22 7CCD23 7FAD11 7FAD12 H731 H731-D1 H731-S1 H732 H732-D1 H732-S1 H732-S2 H741 H742 H771 H772 H781 H782 HF11 HF31 HF32 ZV20 ZV21 ZV22 ZV25 ZV26 ZV27