Singapore HSA registration DE0504028
Schiller medilogAR
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0504028
- Registration Date
- January 14, 2020
- Change Notification Approval Date
- June 18, 2021
- Retention Due Date
- January 13, 2026
Product description
The medilogAR is used to record a 3-channel ECG. The recorder is designed for a measuring duration of more than 24 hours and is therefore worn by the patient throughout the day. The preparation for the recording (attaching electrodes, etc.) is performed by the technician or doctor. Indicated for use on adults and paediatric (>=10kg) patients (healthy or not). A Holter recording/analysis is indicated if the patient is suspected to suffer from: – cardiac arrhythmias (VT, SVT, Blocks, Tachycardia, Bradycardia…) – ST-depression/elevation – long QT – pacemaker failure – respiratory events
Product Owner
- Name
- Schiller AG
- Short Name
- Schiller AG
- Address
- Altgasse 68, CH-6341 Baar, SWITZERLAND
Registrant
- Address
- 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Importer
- Address
- 211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model information
- Model Name(s)
- medilogAR Holter pouch single use Shoulder- and waiststrap medilog recorder ECG 5-wire patient cable medilog 0.8m ECG 7-wire patient cable medilog 0.8m Protective case medilogAR medilogAR medilog DARWIN2
- Model Identifier(s)
- 1A.306000 2.156086 2.156096 2.400176 2.400177 2.610063 3.92074 medilog DARWIN2
About this record
Access comprehensive regulatory information for Schiller medilogAR in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504028 and owned by Schiller AG. The device was registered on January 14, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B