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Singapore HSA registration DE0015674

Schiller AT-102 plus 12-Channel ECG Unit

Singapore flagSingapore·CLASS B·SCHILLER AG·Registered June 10, 2014
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDB00104
HS Code
90181100
Registration information
Registration Number
DE0015674
Registration Date
June 10, 2014
Change Notification Approval Date
May 17, 2019
Retention Due Date
June 09, 2025
Product description
The AT-102 plus is a 12-channel, ECG device used for the recording, analysis and evaluation of ECG Recordings. Recordings made with the AT-102 plus can be used as a diagnostic aid for heart function and heart conditions.
Product Owner
Name
SCHILLER AG
Short Name
SCHILLER AG
Address
Altgasse 68, Postfach, CH-6341 Baar, SWITZERLAND
Registrant
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Name
Gold Lite Pte Ltd Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Model information
Model Name(s)
CARDIOVIT AT-102 plus Set of children ECG electrodes incl. 6 suction Adult clamp extremity electrode, set of 4 pcs SCHILLER Biotabs Ag/AgC, disposable electrodes C Software AT-102 plus C Software incl. Thrombolysis recommendation Thrombolysis Recommendation Software AT-102 plus Worklist Software AT-102 plus Pacemaker Measurement Software PM AT-102 plus
Model Identifier(s)
0.075000 2.000052 2.155020 2.155031 5.075001 5.075002 5.075003 5.075004 5.075007
About this record

Access comprehensive regulatory information for Schiller AT-102 plus 12-Channel ECG Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0015674 and owned by SCHILLER AG. The device was registered on June 10, 2014.

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