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HeartSine Samaritan PAD Defibrillator - HSA Registration DE0006072

Access comprehensive regulatory information for HeartSine Samaritan PAD Defibrillator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0006072 and owned by HeartSine Technologies Ltd.. The device was registered on February 22, 2011.

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 C
DE0006072
HeartSine Samaritan PAD Defibrillator
HSA Registration Number: DE0006072
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Product Description

The HeartSine Samaritan PAD are indicated for use on victims of cardiac arrest who are exhibiting the following signs: unconscious, not breathing and without circulation. The Samaritan PAD are indicated for use on patients greater than eight years old or over 55 lbs (25 kg) when used with the adult samaritan Pad-Pak and indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan Pediatric-Pak.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0006072
Registration Date
February 22, 2011
Change Notification Approval Date
March 03, 2023
Retention Due Date
February 21, 2026
Product Owner
Short Name
HeartSine Technologies Ltd.
Address
207 Airport Road West, Belfast, BT3 9ED, Northern Ireland, UNITED KINGDOM
Registrant
Address
625 ALJUNIED ROAD, ALJUNIED INDUSTRIAL COMPLEX, #04-05A, SINGAPORE 389836
Importer
Address
625 ALJUNIED ROAD, ALJUNIED INDUSTRIAL COMPLEX, #04-05A, SINGAPORE 389836 1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model Information
Model Name(s)
HeartSine samaritan PAD 350P with Gateway Module HeartSine samaritan PAD 360P with Gateway Module HeartSine samaritan PAD with CPR Advisor 500P and Gateway Module HeartSine Gateway Module Adult Pad-Pak Paediatric Pak-Pak Adult Pad-Pak HeartSine samaritan PAD 300P HeartSine samaritan PAD 350P HeartSine samaritan PAD 360P HeartSine samaritan PAD with CPR Advisor 500P
Model Identifier(s)
350-BAS-UK-GW 360-BAS-UK-GW 500-BAS-UK-GW ACC-GTW-UK-01 Pad-Pak-03 Pad-Pak-04 Pad-Pak-07 SAM 300P SAM 350P SAM 360P SAM 500P