Singapore HSA registration DE0501278
Schiller CARDIOVIT FT-1
Singapore·CLASS B·SCHILLER AG·Registered February 23, 2018Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0501278
- Registration Date
- February 23, 2018
- Change Notification Approval Date
- July 22, 2024
- Retention Due Date
- February 22, 2026
Product description
The CARDIOVIT FT-1 is a 12-lead electrocardiograph device intended to be used by or under the direct supervision of a licensed healthcare practitioner in healthcare facilities to acquire ECG signals from body surface electrodes, record, analyse, display and print ECGs for diagnosis in adult and paediatric patients. The CARDIOVIT FT-1 is intended to be used by trained operators under supervision of a licensed healthcare practitioner. The CARDIOVIT FT-1 is intended to support detection and diagnosis of abnormalities in conduction, rhythm, and myocardial perfusion of the heart at rest.
Product Owner
- Name
- SCHILLER AG
- Short Name
- SCHILLER AG
- Address
- Altgasse 68, Postfach, CH-6341 Baar, SWITZERLAND
Registrant
- Address
- 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Importer
- Address
- 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Model information
- Model Name(s)
- ECG Kit ECG Kit Suction electrode 4mm Adult clamp extremity electrode, set of 4 pcs Abrasive pads CARDIO-PREPS, pouch of 50 pcs Replacement bulb for suction electrode 2.155000 ECG 10-wire patient cable, IEC dot clip 2.1m ECG 10-wire patient cable, AHA dot clip 2.1m ECG 10-wire patient cable, IEC banana plug 2.1m ECG 10-wire patient cable, AHA banana plug 2.1m CARDIOVIT FT-1 CARDIOVIT FT-1
- Model Identifier(s)
- 2.000041 2.000052 2.155000 2.155020 2.155030 2.155060 2.400226 2.400227 2.400330 2.400331 3.900863 3.900865
About this record
Access comprehensive regulatory information for Schiller CARDIOVIT FT-1 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501278 and owned by SCHILLER AG. The device was registered on February 23, 2018.
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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